| No Registry |
Status |
Registry |
| |
Recruit
|
Bioequivalence Study of 60 mg Pyridostigmine Bromide Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Mestinon® 60 mg Sugar Coated Tablets Manufactured by Labiana Pharmaceuticals S.L. Spain for A. Menarini Asia-Pacific Holdings Pte. Ltd., Singapore, Imported by PT Menarini Indria Laboratories, Indonesia, Packed and Released by PT Combiphar, Indonesia
|
| |
Complete
|
Bioequivalence study of clopidogrel 75 mg film-coated tablet produced by PT Lapi Laboratories in comparison with the comparator drug (Plavix® 75 mg Film-Coated Tablet manufactured by PT Aventis Pharma, Indonesia, under license by Sanofi Clir SNC, France) when administered under fasting condition in healthy subjects
| Interventions: |
The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one film-coated tablet of the test drug (clopidogrel 75 mg film-coated tablet produced by PT Lapi Laboratories) or one film-coated tablet of the comparator drug (Plavix® 75 mg Film-Coated Tablet manufactured by PT Aventis Pharma, Indonesia, under license by Sanofi Clir SNC, France). |
|
| |
Complete
|
Bioequivalence Study of 2 mg Glimepiride Tablets Manufactured by PT. Interbat (Friladar® 2 Tablet) in Comparison with 2 mg Amaryl® Tablets Manufactured by PT. Aventis Pharma, Indonesia
| Interventions: |
Glimepiride 2 mg tablets |
|
| |
Complete
|
Bioequivalence study of dapagliflozin 10 mg film-coated tablet produced by PT Dexa Medica in comparison with the comparator drug (Forxiga® 10 mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, Indonesia).
| Interventions: |
Test drug: Dapagliflozin 10 mg film-coated tablet produced by PT Dexa Medica
Reference drug: Forxiga® 10 mg Film-Coated Tablet manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, Indonesia
The subjects blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. |
|
| |
Complete
|
Bioequivalence study of Amlodipine 10 mg tablet manufactured by PT Kimia Farma Tbk in comparison with Amlodipine 10 mg tablet, Norvask® manufactured by PT Pfizer Indonesia
| Interventions: |
Amlodipine 10 mg tablet manufactured by PT Kimia Farma Tbk |
|
| |
Complete
|
bioequivalence study of Azithromycin 500 mg film coated caplets, Zycin 500 manufactured by PT Interbat in comparison Azithromycin 500 mg film coated tablets, Zithromax® manufactured by PT Pfizer Indonesia; under licensed by Pfizer Inc. New York, U.S.A
| Interventions: |
Azithromycin 500 mg film coated caplets, Zycin 500 manufactured by PT Interbat |
|
| |
Initial
|
PCV13-004
| Interventions: |
13-valent Pneumococcal Conjugate Vaccine (PCV13-TT) to Healthy Infants |
|
| |
Complete
|
Bioequivalence Study of 20 mg Piroxicam Capsule (Novaxicam®) Manufactured by PT. Novapharin in Compared with 20 mg Feldene® Capsule Manufactured by Pfizer Pharmaceuticals Llc Ireland
| Interventions: |
The reference drug was 20 mg Feldene® Capsule Manufactured by Pfizer Pharmaceuticals Llc Ireland, Batch Number EW4078, Expiry Date June 30th 2024. The test drug was 20 mg Piroxicam Capsule (Novaxicam®) Manufactured by PT. Novapharin, Batch Number 2211-10-47, Manufacturing Date November 09th 2022, Expiry Date November 2024. In sampling day, subject took one dose of Piroxicam manufactured of either formulation (reference or test) as per randomization scheme with 1 capsule of 20 mg (to be taken with 220 mL of water) in sitting position. |
|
| |
Complete
|
Bioequivalence study of Amlodipine 10 mg caplet, Tensiblat® manufactured by PT Harsen Laboratories in comparison with Amlodipine 10 mg tablet, Norvask® manufactured by PT Pfizer Indonesia
| Interventions: |
Amlodipine 10 mg caplet, Tensiblat® manufactured by PT Harsen Laboratories |
|
| |
Complete
|
Bioequivalence study of Amlodipine 10 mg caplet, Tensiblat® manufactured by PT Harsen Laboratories in comparison with Amlodipine 10 mg tablet, Norvask® manufactured by PT Pfizer Indonesia
| Interventions: |
Amlodipine 10 mg caplet, Tensiblat® manufactured by PT Harsen Laboratories |
|
| |
Complete
|
Bioequivalence Study of 300 mg Fenofibrate Capsules Manufactured by PT. Kalbe Farma, Tbk for PT. Hexpharm Jaya in Comparison with 300 mg Lipanthyl® Capsules Manufactured by PT. Combiphar, Bandung, Indonesia for PT. Abbott Indonesia.
| Interventions: |
300 mg Fenofibrate Capsules |
|
| |
Complete
|
Bioequivalence study of Amlodipine 10 mg tablet, Intervask® manufactured by PT Interbat in comparison with Amlodipine 10 mg tablet, Norvask® manufactured by PT Pfizer Indonesia
| Interventions: |
Test Drug : Amlodipine 10 mg tablet, Intervask (BN: ZT0087302) manufactured by PT Interbat |
|
| |
Complete
|
Bioequivalence study of Amlodipine 10 mg tablet manufactured by PT Imedco Djaja in comparison with Amlodipine 10 mg tablet, Norvask® manufactured by PT Pfizer Indonesia
| Interventions: |
Test Drug : Amlodipine 10 mg tablet manufactured by PT Imedco Djaja |
|
| |
Complete
|
BIOEQUIVALENCE STUDY OF ALZIM (10 MG DONEPEZIL HYDROCHLORIDE)
ORODISPERSIBLE TABLET PRODUCED BY PT PRATAPA NIRMALA IN COMPARISON WITH
ARICEPT EVESS (10 MG DONEPEZIL HYDROCHLORIDE) ORODISPERSIBLE TABLET
MANUFACTURED BY BUSHU PHARMACEUTICAL LTD. SAITAMA-KEN, JAPAN, UNDER
THE AUTHORITY OF EISAI CO., LTD. TOKYO, JAPAN, IMPORTED BY PT EISAI INDONESIA,
BOGOR-INDONESIA
| Interventions: |
The reference drug was Aricept Evess (10 mg Donepezil Hydrochloride) orodispersible tablet manufactured by Bushu Pharmaceutical Ltd. Saitama-Ken, Japan, under the authority of Eisai Co., Ltd. Tokyo, Japan, imported by PT Eisai Indonesia, Bogor-Indonesia, batch number 06A23P, manufacturing date 25 May 2020; expiration date on 24 May 2023.
The test drug was Alzim (10 mg Donepezil Hydrochloride) orodispersible tablet produced by PT Pratapa Nirmala, batch number 1AH042; manufacturing date on August 2022; expiration date on August 2024. |
|
| |
Recruit
|
Bioequivalence Study of Nospirinal® 80 mg Enteric Coated Tablet Produced by PT. Novell Pharmaceutical Laboratories in Comparison with CardioAspirin® 100 mg Enteric Coated Tablet Manufactured by Bayer Pharma AG, Germany for Bayer Consumer Care AG, Switzerland Imported by PT Bayer Indonesia
|
| |
Complete
|
Bioequivalence Study of 400 mg Moxifloxacin Film Coated Tablets Manufactured by PT. Mega Lifesciences Indonesia (Moximed) In Comparison with the Innovator's Film Coated Tablets (Avelox) Manufactured by Bayer AG, Leverkusen - Germany, Imported and Packaged by PT. Bayer Indonesia, Depok - Indonesia
| Interventions: |
Bioequivalence Study of 400 mg Moxifloxacin Film Coated Tablets Manufactured by PT. Mega Lifesciences Indonesia (Moximed) In Comparison with the Innovator's Film Coated Tablets (Avelox) Manufactured by Bayer AG, Leverkusen - Germany, Imported and Packaged by PT. Bayer Indonesia, Depok - Indonesia |
|
| |
Complete
|
Bioequivalence study of Fenofibrate 160 mg film-coated tablet (Fenolip Supra 160) produced by PT Meprofarm in comparison with the comparator drug (Lipanthyl® Supra 160 mg Film-Coated Tablet manufactured by Recipharm Fontaine, France, imported by PT Abbott Indonesia, Indonesia) when administered under high fat meal condition in healthy subjects
| Interventions: |
The participating subjects were given orally one film-coated tablet of the test drug (Fenolip Supra 160 produced by PT Meprofarm) 30 minutes after the subjects have consumed a standardized high fat meal as breakfast meal in the first day of each period. |
|
| |
Complete
|
Bioequivalence Study of Ciprofloxacin 500 mg Film-Coated Caplets (Interflox 500) Manufactured by PT. Interbat in Comparison with Ciproxine® 500 mg Film-Coated Tablets Manufactured by Bayer SA-NV (Machelen).
| Interventions: |
Ciprofloxacin 500 mg Film-Coated Caplets (Interflox 500) |
|
| |
Recruit
|
BIOEQUIVALENCE STUDY OF LANSOPRAZOLE 30 MG DELAYED-RELEASE CAPSULE, LAPROTON® MANUFACTURED BY PT TEMPO SCAN PACIFIC TBK IN COMPARISON WITH LANSOPRAZOLE 30 MG DELAYED-RELEASE CAPSULE, PREVACID® MANUFACTURED BY TAKEDA PHARMACEUTICALS AMERICA INC., USA; ENCAPSULATED AND PACKAGED BY ABBOTT LABORATORIES ARGENTINA S.A., ARGENTINA
| Interventions: |
Laproton® (Lansoprazole 30 mg Delayed-Release Capsule) manufactured by PT Tempo Scan Pacific Tbk. |
|
| |
Complete
|
-
| Interventions: |
All subjects fasted at least 10 hours during the night prior to the drug administration. On 29th August 2016 (± 06.30 AM) subjects were instructed to consume one piece of meat bread. At 07.00 AM subjects were instructed to consume one film coated caplet of test or one film coated tablet of reference product with 240 mL of water.
Subjects were given 100 ml of 10% glucose solution per hour for the first four hours after drugs administration to avoid hypoglycemia. No food intake was allowed until 4 hours after drug administration. Water intake was allowed ad libitum one hour before dosing and 2 hours thereafter. Standardized meals were served at 4, 8, and 12 hours after medication. |
|
| |
Complete
|
Bioequivalence Study of 500 mg Azithromycin Film Coated Caplets, Manufactured by PT. Prima Medika Laboratories (Aztrin®), Registered by PT. Pharos Indonesia in Comparison with the Innovator’s Film
Coated Tablets (Zithromax®), Manufactured by PT. Pfizer Indonesia, Jakarta, Indonesia, Under Supervision of Pfizer Inc. New York, N.Y., U.S.A.
| Interventions: |
All subjects were fasted start from 09.00 p.m. to drug administration. On the next day, physician instructed subjects to consume 1 film coated caplet of test product or 1 film coated tablet product with 240 mL of water or equivalent to a glass of mineral water. Before given to subjects, test or reference drug was mixed completely. Investigator were onsite to ensure that each subject swallows the study products. Physician ensured that each subject swallowed the study products. |
|
| |
Complete
|
Bioequivalence study of Etoricoxib 120 mg Film-Coated Tablet, Ricoxa manufactured by PT Interbat in comparison with Etoricoxib 120 mg Film-Coated Tablet, Arcoxia TM manufactured by Rovi Pharma Industrial Services S.A., Madrid, Spain; registered and packed by PT Merck Sharp Dohme Pharma Tbk, Pasuruan, East Java.
| Interventions: |
the test drug Ricoxa (BN: ZT1587201) manufactured by PT Interbat |
|
| |
Complete
|
Bioequivalence Study of 0.5 mg Entecavir Film-Coated Tablet Manufactured by PT. Kalbe Farma, Tbk. for PT. Hexpharm Jaya in Comparison with 0.5 mg Baraclude® Film-Coated Tablet Manufactured by AstraZeneca Pharmaceuticals LP, Indiana, USA and Marketed by Bristol-Myers Squibb, Singapore
| Interventions: |
0.5 mg Entecavir Film-Coated Tablet |
|
| |
Complete
|
Bioequivalence Study of Azithromycin 500 mg Film-Coated Tablets Manufactured by PT. Kimia Farma Tbk Compared to Zithromax® 500 mg Film-Coated Tablets Manufactured by PT. Pfizer Indonesia
| Interventions: |
The reference drug was Zithromax® 500 mg Film-Coated Tablets produced by PT. Pfizer Indonesia, batch number A200168, manufacturing date on September 2020, expired date on August 2024. The test drug was Azithromycin 500 mg fil-coated Tablet produced by PT Kimia Farma Tbk, batch number J03K2403, manufacturing date November 2022, Expired date October 2024. On the sampling day, the subject took one dose of azithromycin manufactured of either formulation (reference or test) as per the randomization scheme with 220 ml water in a seated position. |
|
| |
Complete
|
Bioequivalence Study of Lansoprazole 30 mg Capsule Produced by PT. Novapharin Pharmaceutical Industries Compared to Prevacid® 30 mg Produced by Takeda Pharmaceutical U.S.A., Inc.
| Interventions: |
The reference drug was Prevacid® 30 mg Produced by Takeda Pharmaceutical U.S.A., Inc, batch number 21119QA, manufacturing date on March 2020, expired date on February 2023. The test drug was Lansoprazole 30 mg Capsule Produced by PT. Novapharin Pharmaceutical Industries, batch number 2107-01-273A, manufacturing date July 2021, Expired date July 2023. In sampling day, subject took one dose of Lansoprazole manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position. |
|
| |
Complete
|
Bioequivalence study of montelukast 10 mg film-coated tablet produced by PT Dexa Medica in comparison with the comparator drug (Singulair® 10 mg Film-Coated Tablet manufactured by Merck Sharp & Dohme Ltd., United Kingdom, packed and registered by PT Merck Sharp Dohme Pharma Tbk., Indonesia)
| Interventions: |
Test drug: Montelukast 10 mg film-coated tablet produced by PT Dexa Medica
Reference drug: Singulair® 10 mg Film-Coated Tablet manufactured by Merck Sharp & Dohme Ltd., United Kingdom, packed and registered by PT Merck Sharp Dohme Pharma Tbk., Indonesia
The subjects blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. |
|
| |
Complete
|
Bioequivalence study of Telmisartan 80 mg caplet manufactured by PT Lapi Laboratories in comparison with Telmisartan 80 mg, Micardis tablet manufacutred by Boehringer Ingelheim Pharma GmbH & Co.KG, Ingelheim am Rhein, Germany; for Boehringer Ingelheim Pharma GmbH, Ingelhaim am Rhein, Germany; imported by PT Boehringer Ingelheim Indonesia
| Interventions: |
Telmisartan |
|
| |
Complete
|
Bioequivalence study of azithromycin 500 mg film-coated caplet produced by PT Erlimpex in comparison with the comparator drug (Zithromax® 500 mg Film-Coated Tablet, PT Pfizer Indonesia, under supervision of Pfizer Inc. New York, N.Y., U.S.A)
| Interventions: |
The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one test drug (azithromycin 500 mg film coated caplet produced by PT Erlimpex) |
|
| |
Complete
|
Bioequivalence Study of Bisoprolol Fumarate 10 mg Film-Coated Tablets Manufactured by PT. Lapi Laboratories in Comparison with Concor® 10 mg Film-Coated Tablets Manufactured by PT. Merck Tbk, Jakarta, Indonesia Under License from Merck Healthcare KGaA, Darmstadt, Germany.
| Interventions: |
Bisoprolol Fumarate 10 mg Film-Coated Tablets |
|
| |
Complete
|
Bioequivalence Study of Salbutamol 4 mg Tablet Produced PT. Kimia Farma Tbk. Compared to Ventolin® 2x2 mg Tablet Produced by PT. Glaxo Wellcome Indonesia
| Interventions: |
The reference drug was Ventolin® 2x2 mg Tablet Produced by PT. Glaxo Wellcome Indonesia, batch number 424T, manufacturing date on December 2019, expired date on November 2021. The test drug was Salbutamol 4 mg Tablet Produced PT. Kimia Farma Tbk, batch number A00035NX, manufacturing date January 2020, Expired date January 2022. In sampling day, subject took one dose of Salbutamol manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position. |
|
| |
Complete
|
Bioequivalence Study of Meloxicam 15 mg Tablet Produced PT. Kimia Farma Tbk. Compared to Movi-Cox® 15 mg Tablet Produced by PT. Boehringer Ingelheim Indonesia
| Interventions: |
The reference drug was Movi-Cox® 15 mg Tablet Produced by PT. Boehringer Ingelheim Indonesia, batch number 19020306, manufacturing date on March 2019, expired date on February 2022. The test drug was Meloxicam 15 mg Tablet Produced PT. Kimia Farma Tbk, batch number FP09.E2004.021, manufacturing date May 2020, Expired date April 2022. In sampling day, subject took one dose of Meloxicam manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position. |
|
| |
Complete
|
Bioequivalence Study of Favipirafir 200 mg Film Coated Tablets Produced by PT. Kimia Farma Tbk Compared to Avigan® 200 mg Film Coated Tablets Produced by Fujifilm Toyama Chemical Co., Ltd
| Interventions: |
The reference drug was Avigan® 200 mg Film Coated Tablets Produced by Fujifilm Toyama Chemical Co., Ltd, batch number HG2101A, expired date on Juli 2023. The test drug was Favipiravir 200 mg Tablet produced by PT Kimia Farma Tbk, batch number G10110N, manufacturing date July 27th 20221 Expired date July 27th 2022. In sampling day, subject took one dose of Favipiravir manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position. |
|
| |
Complete
|
Bioequivalence study of Fixed Dose Combination of Levodopa 100 mg and Benserazide 25 mg, Levoben Tablet manufactured by PT Mersifarma Tirmaku Mercusana in comparison with Levodopa 100 and Benserazide 25 mg, Madopar Tablets Distributed in Australia by Roche Products Pty Limited, Level 8, 30-34 Hickson Road Sydney NSW 2000
| Interventions: |
Not applicable |
|
| |
Complete
|
Bioequivalence Study of Carvedilol 25 mg Tablets Manufactured by PT. Kalbe Farma Tbk in Comparison with Dilatrend® 25 mg Tablets Manufactured by Delpharm Milano S.r.l., Via Varnevale, Segrate (MI), Italy under license of Cheplapharm Arzneimittel GmbH, Greifswald, Germany, Imported by DKSH Malaysia Sdn Bhd, Selangor Darul Ehsan, Malaysia.
| Interventions: |
Carvedilol 25 mg Tablet |
|
| |
Complete
|
Bioequivalence Study of Diclofenac Sodium 50 mg Enteric Coated Tablet, Volten Manufactured By PT Promedrahardjo Farmasi Industri In Comparison With of Diclofenac Sodium 50 mg Enteric Coated Tablet, Voltaren Manufactured By Novartis Indonesia
|
| |
Complete
|
Bioequivalence Study of Diclofenac Sodium 50 mg Enteric Coated Tablet, Volten Manufactured By PT Promedrahardjo Farmasi Industri In Comparison With of Diclofenac Sodium 50 mg Enteric Coated Tablet, Voltaren Manufactured By Novartis Indonesia
|
| |
Complete
|
Bioequivalence Study of Zidovudine 100 mg Capsules Produced by Pt Kimia Farma Tbk Compared To Retrovir 100 mg Capsules Produced by Glaxosmithkline Pharmaceuticals S.A
| Interventions: |
The reference drug was Retrovir 100 mg capsules produced by Glaxosmithkline Pharmaceuticals S.A, batch number JN8K, expired date on November 2024. The test drug was Zidovudine 100 mg capsules produced by PT Kimia Farma Tbk, batch number G2 1346 J, manufacturing date July 2022, Expired date July 2025. In sampling day, subject took one dose of Zidovudine manufactured of either formulation (reference or test) as per randomization scheme with 250 mL water in lying position. |
|
| |
Complete
|
Bioequivalence Study of Etoricoxib 120 mg Film-Coated Tablet Produced by PT Kimia Farma Tbk Compared To
Arcoxia 120 mg Film-Coated Tablet Produced by Rovi Pharma Industrial Service
| Interventions: |
The reference drug was Etoricoxib 120 mg Film-Coated Tablet produced by VIRDEV INTERMEDIATES PVT LTD, batch number FP-ETO-015-21, manufacturing date on september 2021, expired date on August 2026. The test drug was Etoricoxib 120 mg Film-Coated Tablet produced by PT Kimia Farma Tbk, batch number FP04.I2212.048, manufacturing date September 12th 2022, Expired date September 2024. In sampling day, subject took one dose of Etoricoxib manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position. |
|
| |
Complete
|
Bioequivalence Study of Ticagrelor 90 mg Film-Coated Tablets Manufactured by PT. Kimia Farma Tbk in Comparison with Brilinta® 90 mg Film-Coated Tablets Manufactured by AstraZeneca AB, Sweden, Packed and Released by AstraZeneca Pharmaceutical Co., Ltd, Jiangsu, China, Imported by PT. AstraZeneca Indonesia, Bekasi, Indonesia.
| Interventions: |
Ticagrelor 90 mg Film-Coated Tablets |
|
| |
Complete
|
Bioequivalence Study of Amlodipine 10 mg Tablet Produced by PT. Kimia Farma Tbk Compared to Norvask® 10 mg Tablet Produced by PT. Pfizer Indonesia
| Interventions: |
The reference drug was Norvask® 10 mg Tablet produced PT. Pfizer Indonesia, batch number FP9902, manufacturing date on December 2022, expired date on January 2024. The test drug was Amlodipine 10 mg Tablet produced by PT Kimia Farma Tbk, batch number B10L2445, manufacturing date December 22th 2022, Expired date December 22th 2024. In sampling day, subject took one dose of Amlodipine manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position. |
|
| |
Complete
|
Bioequivalence Study of 500 mg Ciprofloxacin Film Coated Tablet Produced by PT. Hexpharm Jaya in comparison with 500 mg Ciproxin Film Coated Tablet Produced by PT. Bayer Indonesia
| Interventions: |
Ciprofloxacin 500 mg film coated tablet |
|
| |
Complete
|
Bioequivalence Study of Ethambutol 400 mg Entericcoated Tablet Manufactured by PT. Kimia Farma Tbk Compared to Myambutol 400 mg Film-Coated Tablet Manufactured by Pantheon Inc, Ontario, Canada, for STI Pharma Llc
| Interventions: |
The reference drug was Myambutol Film-Coated Tablet 400 mg produced by Pantheon Inc, Ontario, Canada, for STI Pharma Llc, batch number CFKFD, expired date on November 2023. The test drug was Ethambutol 400 mg Film-Coated Tablet produced by PT Kimia Farma Tbk, batch number J20113NX, Expired date October 2024. In sampling day, subject took one dose of Simvastatin manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position. |
|
| |
Complete
|
Bioequivalence Study of Ethambutol 400 mg Entericcoated Tablet Manufactured by PT. Kimia Farma Tbk Compared to Myambutol 400 mg Film-Coated Tablet Manufactured by Pantheon Inc, Ontario, Canada, for STI Pharma Llc
| Interventions: |
The reference drug was Myambutol Film-Coated Tablet 400 mg produced by Pantheon Inc, Ontario, Canada for STI Pharma Llc, batch number CFKFD, expired date on November 2023. The test drug was Ethambutol 400 mg Tablet produced by PT Kimia Farma Tbk, batch number J20113NX, Expired date October 2024. In sampling day, subject took one dose of Simvastatin manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position. |
|
| |
Complete
|
Bioequivalence Study of 100 mg/5 mL Cefixime Dry Syrup, Manufactured by PT. Pharos Indonesia (Fixiphar®) in Comparison with the Innovator’s Dry Suspension (Suprax®), Manufactured by Odan Laboratories Ltd., Montreal
| Interventions: |
Subject would be fasted during 10 hours and the next morning, physician instructed subjects to consume 10 mL dry syrup of test product or 10 mL dry suspension product with 240 mL of water or equivalent to a glass of mineral water. The drugs was given with catheter tip, before given to subjects, test or reference drug was mixed completely, then washing the catheter tip. Subjct would be instructed to kept sitting or laying on their back rigt after dosing until four (4) hours after dosing. |
|
| |
|
|
| |
Complete
|
Bioequivalence Study of Simvastatin 20 mg Tablets Produced by PT. Kimia Farma Tbk Compared to Zocor 20 mg Tablets Produced by Merck Sharp & Dohme Ltd. United Kingdom
| Interventions: |
The reference drug was Zocor® Tablet 20 mg produced by Merck Sharp & Dohme Ltd United Kingdom, batch number W004945, manufacturing date on November 24th 2021, expired date on November 24th 2023. The test drug was Simvastatin 20 mg Tablet produced by PT Kimia Farma Tbk, batch number G20073NX, manufacturing date July 2022, Expired date July 2024. In sampling day, subject took one dose of Simvastatin manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position. |
|
| |
Complete
|
Bioequivalence Study of Isoniazid 300 mg Tablet Produced by PT Kimia Farma Tbk Compared to Isoniazid 3x100 mg Tablet Produced by Reimser Pharma GMBH
| Interventions: |
The reference drug was Isozid® (Isoniazid 100 mg) tablet manufactured by: Riemser Pharma GmbH An der Wlek 7-17493 Greifswald-Insel Riems, batch number 001060, expired date on May 2025. The test drug was Isoniazid 300 mg tablet manufactured by PT. Kimia Farma Tbk, batch number I20102NX, manufacturing date 14 October 2022, Expired date 13 October 2024. On the sampling day, the subject took one dose of Isoniazid manufactured of either formulation (reference or test) as per the randomization scheme with 220 ml water in sit position. |
|
| |
Complete
|
Bioequivalence Study of Imatinib Mesylate 400 mg Film-Coated Tablets Manufactured by PT Global Onkolab Farma in Comparison with Glivec® 400 mg Film-Coated Tablets Manufactured by Novartis Pharma Stein A.G., Stein, Switzerland, Imported by PT. Novartis Indonesia.
|
| |
Initial
|
Immunogenicity & Safety of IndoVac® as a Homologous Booster Dose Against COVID-19 in Adults Aged 18 Years and Above in Indonesia
| Interventions: |
IndoVac® Vaccine |
|
| |
Complete
|
BIOEQUIVALENCE STUDY OF ISONIAZID 300 MG TABLET PRODUCED BY PT. KIMIA FARMA Tbk COMPARED TO ISOZID 3x100 MG TABLET PRODUCED BY REIMSER PHARMA GMBH
| Interventions: |
Isoniazid 300 mg |
|
| |
Complete
|
Uji Bioekivalensi Santorvastin® 40 FCT (Atorvastatin 40 mg) Produksi PT Sanbe Farma dibandingkan terhadap Lipitor® 40 FCT (Atorvastatin 40 mg) Produksi Pfizer Pharmaceuticals LLC, Puerto Rico, Amerika Serikat diimpor oleh PT Pfizer Indonesia pada Subjek Sehat
| Interventions: |
Pengujian ketersediaan hayati Atorvastatin dari Santorvastin® 40 FCT yang diproduksi PT. Sanbe Farma telah dilakukan secara komparatif pada subjek sehat dengan desain replicate, dan menyilang dalam waktu 3 periode (partial reference-replicated 3-way crossover design) menggunakan Lipitor® 40 FCT (II) sebagai obat komparator dan sampel plasma untuk pengujian.
Obat diberikan dalam keadaan puasa dan dalam posisi duduk pada pukul 06.00–07.00 WIB dengan 220 mL air pada suhu ruang. |
|
| |
Complete
|
Bioequivalence study of celecoxib 200 mg capsule (Celedip® 200) manufactured by PT Dipa Pharmalab
Intersains in comparison with the comparator drug (Celebrex® 200 mg capsule manufactured by Pfizer
Pharmaceuticals LLC, Vega Baja, Puerto Rico, imported and packed by PT Pfizer Indonesia, Indonesia)
| Interventions: |
The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one capsule of the test drug (Celedip® 200 mg capsule manufactured by PT Dipa Pharmalab Intersains) or one capsule of the comparator drug (Celebrex® 200 mg Capsule, manufactured by Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico, imported and packed by
PT Pfizer Indonesia, Indonesia) |
|
| |
Complete
|
Bioavailability/bioequivalence study of Risperidone 1 mg Film Coated Caplets manufactured by PT. Bernofarm, Indonesia in comparison with Risperidone 1 mg, Risperidal® Tablets manufactured by Janssen-Cilag S.p.A., Italy.
| Interventions: |
The test drug was the market available Risperidone 1 mg Film Coated Caplets manufactured by PT Bernofarm, Indonesia; batch number : RST2-19-001E; Manufacturing date : January 17th, 2019; Expired date : January, 2021.
The reference drug was the market available Risperidal® Tablets manufactured by Janssen-Cilag S.p.A., Italy; batch number : IJL4600; Expired date : September 2021.
In sampling day, Subjects took one dose of Risperidone products of either formulation (Reference or Test) after an overnight fasted. As randomization scheme with 240 mL of water in sitting position.
The subjects blood samples was taken at a certain times. |
|
| |
Complete
|
Bioequivalence study of linezolid 600 mg film-coated tablet produced by PT Kimia Farma Tbk. in comparison with the comparator drug (Zyvox® 600 mg Film-Coated Tablet manufactured by Pfizer Pharmaceuticals LLC, Puerto Rico, imported by PT Pfizer Indonesia, Indonesia)
| Interventions: |
The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one test drug (linezolid 600 mg film-coated tablet produced by PT Kimia Farma Tbk.) or one comparator drug (Zyvox® 600 mg Film-Coated Tablet manufactured by Pfizer Pharmaceuticals LLC, Puerto Rico, imported by PT Pfizer Indonesia, Indonesia). |
|
| |
Complete
|
Bioequivalence study of molnupiravir 200 mg capsule produced by PT Kimia Farma Tbk. in comparison with the comparator drug Lagevrio® (Molnupiravir 200 mg Capsule manufactured by Merck Sharp Dohme) when administered under fasting condition in healthy subjects
| Interventions: |
The participating subjects were required to have an 8 hours overnight fast and in the next morning (first day of period) were given orally one capsule of the test drug (Molnupiravir 200 mg Capsule produced by PT Kimia Farma Tbk.) or one capsule of the comparator drug (Lagevrio® 200 mg Capsule manufactured by Merck Sharp Dohme) with total 240 mL of water. |
|
| |
Complete
|
Bioavailability/bioequivalence study of 150 mg Pregabalin Capsules: (Pregabalin 150 mg Kapsul) manufactured by PT Bernofarm in comparison with Pregabalin 150 mg, Lyrica® manufactured by Pfizer Manufacturing Deutschland GmbH, Freiburg Germany; imported by PT Pfizer, Indonesia.
| Interventions: |
The test drug was the market available Pregabalin 150 mg capsules manufactured by PT Bernofarm, Indonesia; batch number : RSK-19-034D; Manufacturing date : September 2019; Expired date : September 2021. The reference drug was the market available Pregabalin 150 mg capsules, Lyrica® manufactured by Pfizer Manufacturing Deutschland GmbH, Freiburg Germany; imported by PT Pfizer, Indonesia.; batch number : AK5479; Expired date : September 2021.
In sampling day, Subjects took one dose of Pregabalin 150 mg capsules products of either formulation (Reference or Test) after an overnight fasted. As randomization scheme with 240 mL of water in sitting position.
The subjects blood samples was taken at a certain times |
|
| |
Complete
|
Bioequivalence study of 300 mg Irbesartan film-coated tablet manufactured by PT Bernofarm in comparison with 300 mg Aprovel® film-coated tablet manufactured by Sanofi Winthrop Industrie, France ; under license by Sanofi Clir SNC, France; imported by PT Aventis Pharma, Jakarta, Indonesia
| Interventions: |
The test drug was the market available Irbesartan 300 mg film-coated tablet manufactured by PT Bernofarm, Indonesia; batch number : RST2-20-025B; Manufacturing date : November 11th, 2020; Expired date : November 11th, 2022. |
|
| |
Complete
|
Uji Bioekivalensi Forbetes® 850 FCT (Metformin HCl 850 mg) Produksi PT Sanbe Farma Dibandingkan terhadap Glucophage® 850 MG fct (Metformin HCl 850 mg) Produksi PT Merck Tbk., Indonesia di Bawah Lisensi Merck Sante SAS, Perancis pada Subjek Sehat.
| Interventions: |
Pengujian ketersediaan hayati metformin dari Forbetes® 850 FCT (I) yang diproduksi PT Sanbe Farma, Indonesia dilakukan secara komparatif pada subjek sehat dengan desain penelitian silang lengkap menggunakan Glucophage® 850 mg FCT (II) produksi PT Merck Tbk., Indonesia di Bawah Lisensi Merck Sante SAS, Perancis sebagai obat komparator dan sampel plasma untuk pengujian. Obat diberikan dalam keadaan puasa dan dalam posisi duduk pada pukul 06.00–07.00 WIB dengan 220 mL air mineral pada suhu ruang. Subjek diberikan larutan glukosa 10% sebanyak 100 mL setiap jam sampai dengan jam ke-3 setelah pemberian obat. |
|
| |
Initial
|
Precision Health Care Program on HbA1c and Diabetes Self-management
| Interventions: |
In this study, the strategies of tailored care for diabetes were divided into 7 steps: (1) Brief deducting teaching; (2) Assessment for self-management level; (3) Brainstorming among patients to share their difficulty on glycaemic target and specific target behaviour; (4) Making a list of patients’ needs then ranking the priorities; (5) Setting a goal and writing action; (6) Follow-up; and (7) Report of goals attempt. Following a brief deducting teaching, two research assistants were involved in delivering the support group and brainstorming. Table 1 shows the specifics tailored care strategies. |
|
| |
Complete
|
Bioequivalence Study of Sildenafil Film Coated Tablets 100 mg Produced by PT. Kimia Farma Tbk. Compared to Viagra 100 mg Film-Coated Tablets Produced by Pfizer
| Interventions: |
The reference drug was Viagra (100 mg Sildenafil) film-coated tablet manufactured by Pfizer batch number B568310, manufacturing date October 2020; expiration date on September 2023. The test drug was Sildenafil (100 mg Sildenafil) film-coated tablet produced by PT Kimia Farma Tbk, batch number FP03.L2129.088; manufacturing date on 29 December 2021; expiration date on 29 December 2023. Subjects were given one dose (1 tablet) of Sildenafil products of either formulation (reference or test), as per randomization scheme with 220 mL of water in a sitting position. |
|
| |
Complete
|
Impacts of Moderate Aerobic Exercise on Adiponectin and Pancreatic β-cell Function in Males with Type 2 Diabetes : a Randomized Controlled Trial
| Interventions: |
Kelompok uji coba menjalani program latihan aerobik yang diawasi selama 4 minggu dengan intensitas sedang, dengan durasi 30 menit per sesi dan frekuensi 3 sesi per minggu.
Tekanan darah, detak jantung, dan saturasi oksigen diukur sebelum dan sesudah setiap sesi.
Pengambilan sampel darah 30 menit sebelum latihan dan setelah sesi terakhir.
Pengukuran glukosa darah |
|
| |
Complete
|
Bioequivalence Study of 40 mg Furosemide Tablets Manufactured by PT. Bernofarm in Comparison with 40 mg Lasix® Tablets Manufactured by PT. Aventis Pharma, Indonesia.
| Interventions: |
subjects were given a single dose of 40 mg Furosemide of test drug or of reference drug with 240 mL of water. Subjects were administered the drug products in sitting posture. Subjects were asked to maintain upright position (standing or sitting) for 1 hour after dosing.
The subjects should remain in a comfortable recumbent position for up to 8 hours after dosing and remain under medical surveillance for up to 12 hours after dosing. Before they were allowed to ambulate, they should sit up with legs in a dependent position for one minute prior to standing up. While standing immobile, they should be closely observed for blood pressure changes and/or orthostatic symptoms, including nausea, dizziness, or faintness for at least three minutes. |
|
| |
Complete
|
Bioequivalence Study of Deferasirox 500 mg Dispersible Tablets Manufactured by PT. Kalbe Farma Tbk for PT. Dankos Farma
| Interventions: |
Subjects were given a single dose of 500 mg deferasirox of either formulation (test or reference) with 240 ml of water. Tablets should not be chewed or swallowed whole. The drug was completely dispersed by stirring in a glass of water (100 to 200 ml) until a fine suspension was obtained. Subjects administered the suspension in sitting posture. After swallowing the suspension, any residue were re-suspended in the remaining water, and swallowed all. Subjects were asked to maintain upright position (standing or sitting) for 1 hour after dosing. |
|
| |
Complete
|
BIOEQUIVALENCE STUDY OF SPIRONOLACTONE 100 MG FILM-COATED TABLET PRODUCED BY PT DEXA MEDICA IN COMPARISON WITH THE COMPARATOR DRUG (ALDACTONE® 100 MG FILM-COATED TABLET, MANUFACTURED BY PFIZER AUSTRALIA PTY LTD, AUSTRALIA)
| Interventions: |
Spironolactone 100 mg produced by Dexa Medica, Batch no A-18138-01-F-PSC-11 |
|
| INA-KDMFZ3 |
Complete
|
Bioequivalence study of Aripiprazole 10 mg, Arinia - 10 Tablets manufactured by PT Meprofarm Pharmaceutical Industries in comparison with Aripiprazole 10 mg, Abilify® 10 Tablets manufactured by Korea Otsuka Pharmaceutical Co. Ltd., Korea. Imported By PT Otsuka Indonesia.
| Interventions: |
The test drug was Arinia (Aripiprazole 10 mg) tablet manufactured by Meprofarm, batch number R0K141, manufacturing date October 2020, Expired date October 2022. |
|
| |
Complete
|
Uji Bioekivalensi Forbetes® 500 FCT (Metformin HCl 500 mg) Produksi PT Sanbe Farma Dibandingkan terhadap Glucophage® 500 mg FCT (Metformin HCl 500 mg) Produksi PT Merck Tbk., Indonesia di Bawah Lisensi Merck Sante Sas, Perancis pada Subjek Sehat
| Interventions: |
Pengujian ketersediaan hayati metformin dari Forbetes® 500 FCT (I) yang diproduksi PT Sanbe Farma dilakukan secara komparatif pada subjek sehat dengan desain penelitian silang lengkap menggunakan Glucophage® 500 mg FCT (II) Produksi PT Merck Tbk., Indonesia di Bawah Lisensi Merck Sante Sas, Perancis sebagai obat komparator dan sampel plasma untuk pengujian. Obat diberikan dalam keadaan puasa dan dalam posisi duduk pada pukul 06.00–07.00 WIB dengan 220 mL air mineral pada suhu ruang. Subjek diberikan larutan glukosa 10% sebanyak 100 mL setiap jam sampai dengan jam ke-3 setelah pemberian obat. |
|
| |
Recruit
|
UNAIR Inactivated COVID-19 Vaccine as Heterologue Booster (Immunobridging Study)
| Interventions: |
INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg. One dose 0.5 ml containing 5 µg inactivated SARS-CoV-2 virus, Tween 80, histidine, Polysorbate 80, Aluminium hydroxide gel, and sodium chloride. |
|
| |
Complete
|
Bioequivalence Study of 100 mg Ericfil ® Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Viagra ® 100 mg Film Coated Tablets Produced by Pfizer, France
| Interventions: |
The reference drug was VIAGRA ® film-coated tablets (100 mg Sildenafil), Lot Number A325402B; Manufacturing date unknown; Expiry date February 2018; manufactured by Pfizer, France. The test drug was Ericfil ® film-coated tablets (100 mg Sildenafil), Batch Number 18L245; Manufacturing date November 2016; Expired Date November 2018; produced by PT Novell Pharmaceutical Laboratories. Each subject received a single oral dose of one FC tablet of 100 mg Ericfil® or Viagra® after an overnight fast for at least 10 hours. The dose was taken at ± 07.00 am with 240 ml of water. Water intake was allowed one hour before and one hour after the dose. |
|
| |
Complete
|
Bioequivalence Study of Etoricoxib 120 mg Film-Coated Tablets Manufactured by PT. Lloyd Pharma Indonesia (Coxiloid 120 mg) in Comparison with Arcoxia® 120 mg Film-Coated Tablets Manufactured by Rovi Pharma Industrial Services S.A., Spain, registered by PT. Merck Sharp Dohme Pharma Tbk, Indonesia.
| Interventions: |
Subjects were given a single dose of etoricoxib 120 mg of either formulation (test or reference) with 240 mL of water. Subjects were taken the drug products in sitting posture. The tablet was swallowed whole without chewing or crushing. Subjects were asked to maintain upright position (standing or sitting) for 1 hour after dosing |
|
| |
Complete
|
Uji Klinis Vaksin Monovalent SARS-CoV-2 mRNA Varian Omicron BA.4/5
| Interventions: |
Vaksin Uji: SARS-CoV-2 Variant (BA.4/5) mRNA Vaccine (ABO1020)
Plasebo: Physiological Saline Injection |
|
| |
Complete
|
Uji Klinis Vaksin Monovalent SARS-CoV-2 mRNA Varian Omicron BA1 dan Delta
| Interventions: |
Omicron Vaccine: ABO1009-DP
Delta Vaccine: ABO-CoV.617.2
Placebo: Normal saline |
|
| INA-KOE6FKH |
Complete
|
Bioequivalence study of Miozidine MR (35 mg Trimetazidine) film-coated tablet produced by PT Pratapa Nirmala in comparison with Trizedon MR (35 mg Trimetazidine) film-coated tablet manufactured by PT Darya-Varia Laboratoria Tbk, under license of Servier-France.
| Interventions: |
The reference drug was Trizedon® MR (35 mg Trimetazidine) film coated tablet manufactured by PT Darya-Varia Laboratoria Tbk, under license of Servier-France, batch number MX1A063, manufacturing date December 2021; expiration date on December 2024.
The test drug was Miozidine MR (35 mg Trimetazidine) film coated tablet produced by PT Pratapa Nirmala, batch number 1AJ062; manufacturing date on October 2022; expiration date on October 2024.
Subjects were given one dose of Trimetazidine products of either formulation (reference or test), as per randomization scheme with 240 mL of water in sitting position. |
|
| |
Complete
|
BIOEQUIVALENCE STUDY OF GLUDITIN (100 MG SITAGLIPTIN) FILM COATED TABLET PRODUCED BY PT KONIMEX IN COMPARISON WITH JANUVIA (100 MG SITAGLIPTIN) TABLET PRODUCED BY MERCK SHARP & DOHME LTD., ENGLAND IMPORTED BY PT MERCK SHARP DOHME PHARMA TBK. INDONESIA
| Interventions: |
This study will assess the bioequivalence of Gluditin (100 mg Sitagliptin Phosphate) film coated tablet produced by PT Konimex in comparison with Januvia® (100 mg Sitagliptin Phosphate) tablet produced by Merck Sharp & Dohme Ltd. Cramlington, England, imported by PT Merck Sharp Dohme Pharma Tbk. |
|
| |
Complete
|
Bioequivalence Study of 500 mg Clarithromycin XR Extended Release Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Abbotic® XL 500 mg Modified Release Film Coated Tablets Produced by PT. Abbot Indonesia.
| Interventions: |
The reference drug was the market available Abbotic® XL 500 mg Modified Release Film Coated Tablets (Produced by PT. Abbot Indonesia) batch number 28724XP; manufacturing date Mei 2021; expiration date Mei 2023. The test drug was Clarithromycin XR Extended Release Film Coated Tablets produced by PT Novell Pharmaceutical Laboratories, batch number D21I04 manufacturing date Oktober 2021; expiration date September 2023. In the sampling day, each subject received a single oral dose of 500 mg Clarithromycin, either as test or reference formulation administered along with 220 mL of water. The dose was taken at 07.00 am after an overnight fast for at least 8 hours. Water intake was allowed except for one hour before and one hour after the dose. |
|
| INA-H99SEE8 |
Complete
|
Bioequivalence study of Clopidogrel 75 mg film coated tablet produced by PT Pratapa Nirmala in comparison with Plavix® (75 mg Clopidogrel) film coated tablet manufactured by PT Aventis Pharma, Indonesia under license of Sanofi Clir SNC, France.
| Interventions: |
The reference drug was Plavix® (75 mg Clopidogrel) film coated tablet manufactured by PT Aventis
Pharma, Indonesia under license of Sanofi Clir SNC, France, batch number 2DN061, manufacturing
date December 2020; expiration date on November 2023.
The test drug 1 was Clopidogrel 75 mg film coated tablet produced by PT Pratapa Nirmala, batch
number 1AH149; manufacturing date on August 2022; expiration date on August 2024.
The test drug 2 was Clopidogrel 75 mg film coated tablet produced by PT Pratapa Nirmala, batch
number 1AI001; manufacturing date on September 2022; expiration date on September 2024.
Subject took one dose of Clopidogrel products (tests or reference), as per randomizaton scheme with 240 mL of water in sitting position. |
|
| INA-CPE6Y84 |
Complete
|
Bioequivalence study of clopidogrel 75 mg film-coated tablet produced by PT Dexa Medica in comparison with the comparator drug (Plavix® 75 mg Film-Coated Tablet manufactured by PT Aventis Pharma, Indonesia, under license by Sanofi Clir SNC, France) when administered under fasting condition in healthy subjects
| Interventions: |
Test drug Clopidogrel 75 mg film-coated tablet produced by PT Dexa Medica
Reference drug: Plavix® 75 mg Film-Coated Tablet manufactured by PT Aventis Pharma, Indonesia, under license by Sanofi Clir SNC, France.
The subjects blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. |
|
| INA-NLTZSWG |
Complete
|
Bioequivalence Study of Cefixime 100 mg Capsule Produced by PT. Pharma Laboratories in Comparison with Cefspan® (100 mg Cefixime) Capsule Manufactured by PT. Dankos Farma, for PT. Kalbe Farma Tbk., under License of Astellas Pharma Inc.
|
| INA-0E8MRMC |
Complete
|
Bioequivalence Study of 300 mg Fenofibrate Capsules Manufactured by PT. Catur Dakwah Crane Farmasi for PT. Pharma Laboratories in Comparison with 300 mg Lipanthyl® Capsules Manufactured by PT. Combiphar, Bandung, Indonesia for PT. Abbott Indonesia, Indonesia
|
| INA-FW91Q3G |
Complete
|
Bioequivalence Study of Febuxostat 80 mg Film Coated Tablets Manufactured by PT. Bernofarm for PT. Infion in Comparison with Feburic® 80 mg Film Coated Tablets Manufactured by Patheon France SA, imported by PT. Meprofarm Pharmaceutical Industries.
| Interventions: |
Subjects were given a single dose of 80 mg Febuxostat of either formulation (test or reference) with 240 ml of water. Subjects were administered the drug products in a sitting posture. The tablet was swallowed whole without chewing or crushing. Subjects were asked to maintain an upright position (standing or sitting) for 1 hour after dosing. |
|
| INA-EMAMLXK |
Complete
|
Bioequivalence Study of 20 mg Omeprazole Delayed Release Capsule Manufactured by PT. Bernofarm in Comparison with 20 mg Losec® Capsule Manufactured by AstraZeneca AB, Sweden, Imported by AstraZeneca, Indonesia
| Interventions: |
Subjects were given a single dose of 1 tablet of 20 mg omeprazole of either formulation (test or reference) with 240 ml of water. Subjects were administered the drug products in a sitting posture. Subjects were asked to maintain upright position (standing or sitting) for 1 hour after dosing. |
|
| INA-3TBDPZ1 |
Complete
|
Home-Based Foot-Ankle Exercise Efektif Meningkatkan Ankle Brachial Index Pada Pasien Diabetes Mellitus Tipe 2: Randomized Controlled Trial
| Interventions: |
Responden dibagi menjadi 2 kelompok yaitu kelompok intervensi dan kontrolRandomisasi dilakukan oleh peneliti dengan menggunakan randomisasi blok. Randomisasi dilakukan oleh orang yang independen dari tim peneliti untuk memastikan peneliti dan peserta tidak mengetahui alokasi. Jumlah subjek dibagi 2 sama besar, dimana dalam 1 blok terdapat 4 subjek sehingga terdapat 6 variasi blok. Peserta secara acak dimasukan kedalam grup menggunakan tabel blok (angka) yang dihasilkan dengan bantuan komputer. Nomor acak yang dihasilkan komputer kemudian ditempatkan dalam amplop buram tersembunyi dan diberikan berdasarkan nomor urut kedatangan responden. Responden tidak mengetahui apakah mereka masuk kedalam kelompok intervensi atau kelompok kontrol
Peneliti melibatkan 2 orang peneliti pendamping yang sudah memiliki sertifikat GCP (Good Clinical Practice). Peneliti pendamping bertugas membantu peneliti utama untuk melatih, mengawasi dan melakukan kunjungan rumah serta melakukan observasi pelaksanaan Home- Based Foot–Ankle Exercise pada kelompok intervensi dan senam kaki diabetes pada kelompok kontrol. Tingkat persamaan persepsi antara peneliti dan asisten peneliti mengenai pelaksanaan Home- Based Foot–Ankle Exercise dan latihan senam kaki diabetes telah dilakukan uji kesepakatan dengan menggunakan metode interpreter reliability yaitu dengan uji Kappa. Hasil pengujian analisis dengan menggunakan uji kappa pada asisten penelitian 1 diperoleh hasil nilai kofisien kappa 0,794 (>0,6) dan hasil nilai kofisien kappa antara peneliti utama dan asisten penelitian 2 yaitu 0,659 (>0,6).
Pada kedua kelompok Peneliti dan asisten peneliti melakukan pemeriksaan gula darah 2 kali seminggu sebelum latihan atau apabila terdapat tanda & gejala hipoglikemi pada pasien (edukasi diberikan diawal tentang tanda dan gejala hipoglikemi, pencegahan dan penanganan)
Pada kedua kelompok 1 jam sebelum latihan, responden diinstruksikan untuk makan (mencegah hipoglikemi)
Sehari sebelum intervensi yang pertama dilakukan pengukuran ABI pada kelompok intervensi dan kontrol (pretest)
Pada kelompok intervensi diberikan perlakuan Home Based Foot–Ankle Exercise yang terdiri dari 4 kategori gerakan yang dibagi menjadi 10 jenis gerakan yaitu Foot ankle stretching exercises & Ankle Range of Motion terdiri dari gerakan Heel Cord Stretch, Heel Cord Stretch with Bent Knee dan Ankle Range of Motion; Foot ankle strengthening exercises terdiri dari gerakan Golf Ball Roll, Calf Raises, Marble Pickup dan Towel Scrunch; Foot ankle resistance exercises terdiri dari gerakan Calf stretching/ Towel Stretch dan Resistive Exercises with Theraband; serta Balance exercises terdiri dari gerakan Balance Disc.
Pada kelompok kontrol diberikan perlakuan senam kaki diabetes yang terdiri dari 7 gerakan.
Perlakuan pada kelompok intervensi dan kontrol dilakukan 5 kali dalam seminggu (satu kali perhari) selama 24 kali pertemuan. Sebelum dilakukan intervensi pada kedua kelompok, responden dilakukan pengukuran gula darah sewaktu. Responden yang memiliki kadar gula darah < 100 mg/dL, maka akan ditunda latihan dan diberikan terapi hipoglikemi.
Peneliti dan asisten peneliti melakukan pengawasan pelaksanaan Home- Based Foot–Ankle Exercise (pada kelompok intervensi) dan senam kaki diabetes (pada kelompok kontrol) dengan cara melakukan kunjungan ke rumah responden sebanyak dua kali seminggu dan pengawasan menggunakan panggilan video (video call) yang didampingi oleh satu orang anggota keluarga sebanyak tiga kali seminggu
Postetest dilakukan keesokan harinya setelah intervensi ke 24 (1 hari setelah intervensi ke 24).
Penilaian ABI pretest dan postest dilakukan oleh seorang assessors atau evaluator yang tidak terlibat dalam pemberian intervensi pada penelitian ini. Asesor tidak mengetahui apakah responden tersebut masuk kedalam kelompok intervensi atau kelompok kontrol (blinded). Assessors tersebut sebelumnya sudah dilakukan pelatihan tentang cara pengukuran ABI dan uji persamaan persepsi dengan uji kappa (nilai uji kappa 0,874).
Instrumen penelitian ini dibagai menjadi 3 yaitu kuesioner karakteristik responden, instrumen pengukuran gula darah sewaktu menggunakan glukotest (glukometer) yang sudah dilakukan kalibrasi, instrumen pengukuran ABI menggunakan Spignomanometer dan Doppler portable 8 MHz yang sudah dilakukan kalibrasi |
|
| INA-PNPOLL5 |
Complete
|
Bioequivalence Study of Febuxostat 80 mg Film Coated Tablets Manufactured by PT. Bernofarm for PT. Infion in Comparison with Feburic® 80 mg Film Coated Tablets Manufactured by Patheon France SA, imported by PT. Meprofarm Pharmaceutical Industries.
| Interventions: |
The participating subjects were given orally one film-coated caplet of test drug (febuxostat 80 mg film-coated caplet produced by PT Darya-Varia Laboratoria Tbk.) or one film-coated tablet of comparator drug (Feburic® 80 mg Film-Coated Tablet manufactured by Patheon France, S.A., France, imported by PT Meprofarm Pharmaceutical Industries, Indonesia) |
|
| INA-ENHTMO9 |
Complete
|
BIOEQUIVALENCE STUDY OF FARSORBID® 5 (5 MG ISOSORBIDE DINITRATE) SUBLINGUAL TABLET PRODUCED BY PT PRATAPA NIRMALA IN COMPARISON WITH CEDOCARD 5 (5 MG ISOSORBIDE DINITRATE) SUBLINGUAL TABLET MANUFACTURED BY PT DARYA-VARIA LABORATORIA TBK, UNDER LICENSE OF TAKEDA NETHERLAND B.V.
| Interventions: |
The reference drug was the market available Cedocard® 5 (5 mg Isosorbide Dinitrate) sublingual tablet manufactured by PT Darya-Varia Laboratoria Tbk., under license of Takeda Netherland B.V., batch number LX1A057, manufacturing date on November 2021; expiration date on November 2024.
The test drug was Farsorbid® 5 (5 mg Isosorbide Dinitrate) sublingual tablet produced by PT. Pratapa Nirmala, batch number FG 0801; manufacturing date on July 2021; expiration date on July 2023.
subjects took 1 dose of ISDN products of either formulation (reference or test) as per randomization scheme in sitting position as scheduled. Subject took a glass of water (240 mL) 10-15 minutes before drug administration. After that subject was asked to put the tablet under the tongue and wait until the drug dissolved. |
|
| INA-5S6XPK |
Complete
|
Bioequivalence Study of Clonazepam 2 mg Tablets Manufactured by PT. Sunthi Sepuri in Comparison with Rivotril® 2 mg Tablets Manufactured by Roche Farma S.A., Spain
| Interventions: |
Subjects were given a single dose of 2 mg clonazepam tablet of either formulation (test or reference) with 240 mL of water |
|
| INA-E3QOQ98 |
Complete
|
Bioequivalence Study of 500 mg Divalproex Sodium Extended Release Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Depakote ER 500 mg Extended Release Tablets Manufactured by PT. Abbott Indonesia
| Interventions: |
Tablet batch number 25418XP manufacturing date 1 February 2021, expiration date 1 February 2023. The test drug was Divalproex Sodium Extended Release FC Tablets produced by PT. Novell Pharmaceutical Laboratoirs, batch number D21E06 manufacturing date June 2021 , expiration date May 2023. In the sampling day, each subject received a single-oral dose of 500 mg Divalproex Sodium, either as test or reference formulation administered along with 220 mL of water. The dose was taken at 07.00 am after an overnight fast for ar least 8 hours. Water intake was allowed except for one hour before and one hour after the dose |
|
| |
Complete
|
NA
|
| INA-3XEGQ4S |
Complete
|
Bioequivalence Study of Gliclazide 60 mg Modified Release Tablets manufactured by PT Kimia Farma in comparison with Gliclazide 60 mg, Diamicron® Modified Release Tablets manufactured by Les Laboratories Servier – France, Registered by PT Darya Varia Laboratoria Tbk Bogor - Indonesia, Imported and Marketed by PT Servier Indonesia
| Interventions: |
Subjek diberikan 60 mg Gliclazide Modified Release Tablet yang diproduksi oleh PT Kimia Farma Tbk atau 60 mg Diamicron® Modified Release Tablet yang diproduksi oleh Les Laboratories Servier – France, yang diregistrasikan oleh PT Darya Varia Laboratoria Tbk Bogor – Indonesia, serta diimpor dan dipasarkan oleh PT Servier Indonesia Pfizer Healthcare Ireland dengan 240 mL air glukosa 20% setelah puasa 10 jam. Selanjutnya dilakukan periode washout 7 hari dan prosedur pemberian obat diulang untuk obat selanjutnya sesuai urutan yang telah ditentukan. |
|
| INA-NN8ZFR4 |
Complete
|
BIOEQUIVALENCE STUDY OF LEVOFLOXACIN 500 MG FILM-COATED CAPLET (VOLOX® FILM COATED-CAPLET) PRODUCED BY PT INTERBAT IN COMPARISON WITH THE COMPARATOR DRUG (CRAVIT® 500 MG FILM-COATED TABLET)
| Interventions: |
The participating subjects were given orally one test drug (levofloxacin 500 mg film-coated caplet produced by PT Interbat) or one comparator drug (Cravit® 500 mg Film-Coated Tablet manufactured by PT Kalbe Farma Tbk., Indonesia, under license of Daiichi Sankyo Co., Ltd., Japan) after an overnight fast with 200 mL of water. |
|
| INA-PYC9CAA |
Complete
|
Bioequivalence Study of Glibenclamide 5 mg Caplet Produced by PT First Medipharma in Comparison with Daonil (5 mg Glibenclamide) Tablet Produced by PT Aventis Pharma, Jakarta - Indonesia
| Interventions: |
Test drug: Glibenclamide caplet 5 mg produced by PT First Medipharma - Indonesia. Reference drug: Daonil® (5 mg Glibenclamide) Tablet produced by PT Aventis Pharma - Indonesia. The subjects were asked to stay and fasted overnight (not less than 10 h) prior to the day of study. The subjects blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. |
|
| INA E092TGE |
Complete
|
Bioequivalence Study of 160 mg Valsartan / 10 mg Amlodipine (Vamlopin ®) Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Exforge ®Film Coated Tablets (160 mg Valsartan / 10 mg Amlodipine) Manufactured by Novartis Farmaceutica SA, Spain for Novartis Pharma AG, Switzerland, Imported by PT. Novartis Indonesia
| Interventions: |
The reference drug was Exforge ® film-coated tablets (160 mg Valsartan / 10 mg Amlodipine), Batch Number BPV03; Manufacturing date March 2020; Expiry date February 2023; manufactured by Novartis Farmaceutica SA, Spain for Novartis Pharma AG, Switzerland, Imported by PT. Novarrtis Indonesia.
The test drug was Vamlopin ® film-coated tablets (160 mg Valsartan / 10 mg Amlodipine), Batch Number D20G01; Manufacturing date July 2020; Expired Date July 2022; produced by PT Novell Pharmaceutical Laboratories.
Each subject received a single oral dose of one film-coated tablet of 160 mg Valsartan/10 mg Amlodipin, either as test or reference formulation were given with 220 mL of water. The dose was taken at 07.00 am after an overnight fast for at least 8 hours. Water intake was allowed except for one hour before and one hour after the dose |
|
| INA LTKMPXL |
Complete
|
Bioequivalence study of Aspirin 100 mg, Aptor enteric coated tablet manufactured by PT Nicholas Laboratories Indonesia in comparison with Aspirin 100 mg, Cardio Aspirin ® enteric coated tablets manufactured by Bayer Pharma AG, Leverkusen - Germany for Bayer Consumer Care AG, Switzerland; imported by PT Bayer Indonesia
| Interventions: |
The References drug, Cardio Aspirin (Aspirin 100mg) enteric coated tablets manufactured by Bayer Pharma AG, Leverkusen - Germany for Bayer Consumer Care AG, Switzerland; imported by PT Bayer Indonesia; Batch Number BXJK5T1; Manufacturing Date on December 2020; Expired Date on December 2023.
The Test Drug, Aptor (Aspirin 100mg) enteric coated tablet manufactured by PT Nicholas Laboratories Indonesia Batch Number 2C 100322, Manufacturing Date on March 2022; Expired Date on March 2024.
In sampling day, subject took 1 dose of aspirin products of either formulation (Reference or Test) With 240 mL water according to randomization in each periods in sitting position. |
|
| INA-MTZ4N9R |
Complete
|
Bioequivalence Study of 50 mg/1000 mg Sitagliptin and Metformin Film-Coated Caplets Manufactured by PT. Lapi Laboratories in Comparison with 50 mg/1000 mg Janumet® Film-Coated Caplets Manufactured by Patheon Puerto Rico, Inc., Manati, Puerto Rico, USA. Released by Merck Sharp & Dohme BV, Haarlem Netherlands, registered by PT. Merck Sharp Dohme Pharma Tbk, Pasuruan - Indonesia
| Interventions: |
subjects were given a single dose of 1 caplet of either formulation (test or reference) with 240 ml of a 20% glucose solution in water. The caplet was swallowed whole without chewing or crushing. Subjects administered the drug products in sitting posture. Every 15 minutes subjects were administered of 60 mL of the glucose solution for up to 4 hours after dosing. Subjects were asked to maintain upright position (standing or sitting) for 1 hour after dosing. |
|
| INA-E092TGE |
Complete
|
Bioequivalence Study of 2 mg Dienogest Tablets Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in Comparison with Visanne® Tablets Manufactured by Bayer Weimar GmbH und Co. KG, Germany Imported by PT. Bayer Indonesia
| Interventions: |
The reference drug was the market available Visanne® Tablet batch number WET75U manufacturing date February 2020, expiration date February 2023. The test drug was Dienogest 2 mg Tablet produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratoirs, batch number EEE316 manufacturing date June 2021 , expiration date June 2023. In the sampling day, each subject received a single-oral dose of 2 mg Dieogest, either as test or reference formulation administered along with 220 mL of water. The dose was taken at 07.00 am after an overnight fast for ar least 8 hours. Water intake was allowed except for one hour before and one hour after the dose |
|
| INA-6DH9H6R |
Complete
|
Bioequivalence study of atorvastatin 20 mg film coated tablet produced by PT Otto Pharmaceutical Industries for PT Pertiwi Agung in comparison with the comparator drug (Lipitor® 20 mg Film Coated Tablet manufactured by Pfizer Pharmaceuticals LLC Vega Baja Puerto Rico, USA; packed and released by Pfizer manufacturing Deutschland GmbH, Germany; imported by PT Pfizer Indonesia) when administered under fasting condition in healthy subjects
| Interventions: |
The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one film-coated tablet of test drug (atorvastatin 20 mg film coated tablet produced by PT Otto Pharmaceutical Industries for PT Pertiwi Agung) or one film-coated tablet of comparator drug (Lipitor® 20 mg Film Coated Tablet manufactured by Pfizer Pharmaceuticals LLC Vega Baja Puerto Rico, USA; packed and released by Pfizer manufacturing Deutschland GmbH, Germany; imported by PT Pfizer Indonesia) |
|
| INA-MEKSM9A |
Complete
|
Bioequivalence study of moxifloxacin hydrochloride 400 mg film-coated caplet produced by PT Dexa Medica in comparison with the comparator drug (Avelox® 400 mg Film-Coated Tablet, manufactured by Bayer AG, Leverkusen, Germany, imported by PT Bayer Indonesia, Indonesia).
| Interventions: |
Test drug: Moxifloxacin hydrochloride 400 mg film-coated caplet produced by PT Dexa Medica.
Reference drug: Avelox® 400 mg Film-Coated Tablet, manufactured by Bayer AG, Leverkusen, Germany, imported by PT Bayer Indonesia, Indonesia.
The subjects blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. |
|
| INA-98KBMQ4 |
Complete
|
Bioequivalence study of tenofovir disoproxil fumarate/emtricitabine 300 mg/200 mg film-coated tablet produced by PT Kimia Farma Tbk. in comparison with the comparator drug (Truvada® 300 mg/200 mg Tablet manufactured by Patheon Inc., Canada, under license of Gilead Sciences Inc., USA, imported by Gilead (Shanghai) Pharmaceutical Technology Co. Ltd., China) when administered under fed condition in healthy subjects
| Interventions: |
The participating subjects were given orally one film-coated tablet of test drug (tenofovir disoproxil fumarate/emtricitabine 300 mg/200 mg film coated tablet produced by PT Kimia Farma Tbk.) or one tablet of comparator drug (Truvada® 300 mg/200 mg Tablet manufactured by Patheon Inc., Canada, under license of Gilead Sciences Inc., USA, imported by Gilead (Shanghai) Pharmaceutical Technology Co. Ltd., China) 30 minutes after the subjects have consumed a standardized high fat meal as breakfast meal in the first day of each period. Subjects had to ingest this meal within 30 minutes or less. |
|
| INA-15RFOKE |
Complete
|
Bioequivalence study of 10/160 mg amlodipine/valsartan combination film-coated tablet produced by PT Dexa Medica in comparison with the comparator drug (Exforge® 10/160 mg Film-Coated Tablet, Novartis Farmaceutica SA, Spain for Novartis Pharma AG, Switzerland imported by PT Novartis Indonesia)
| Interventions: |
Test drug: Valsartan/Amlodipine combination film-coated tablet 160/10 mg produced by PT Dexa Medica.
Reference drug: Exforge® 10/160 mg Film-Coated Tablet, Novartis Farmaceutica SA, Spain for Novartis Pharma AG, Switzerland imported by PT Novartis Indonesia.
The subjects blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. |
|
| INA-M05FOH8 |
Initial
|
Immunogenicity and Safety of IndoVac® as a Heterologous Booster Dose Against COVID-19 in Children 12-17 Years of Age
| Interventions: |
Subjects who have previously received complete primary series of inactivated (Sinovac®) COVID-19 vaccine with the last dose administered a minimum of 6 months prior to inclusion but not longer than 12 months prior to inclusion will be given a booster dose of IndoVac vaccine. |
|
| INA-F31CX8K |
Complete
|
BIOEQUIVALENCE STUDY OF PREGABALIN 75 MG CAPSULES MANUFACTURED BY PT. MAHAKAM BETA FARMA IN COMPARISON WITH LYRICA® 75 MG CAPSULES MANUFACTURED BY PFIZER MANUFACTURING DEUTSCHLAND GMBH, FREIBURG, GERMANY, IMPORTED BY PT. PFIZER INDONESIA, JAKARTA
| Interventions: |
Penelitian ini dilakukan dengan memberikan kepada masing-masing subjek uji BE obat inovator dan obat uji dengan kandungan yang sama. Obat uji: Kapsul Pregabalin 75 mg produksi PT. Mahakam Beta Farma. Obat inovator: Kapsul Lyrica® produksi Pfizer Deutschland, Gmbh, Freiburg, Germany diimpor oleh PT. Pfizer Indonesia, Jakarta |
|
| INA-YFRGA38 |
Complete
|
Bioequivalence study of Efavirenz 600 mg Film-Coated Tablet, Efanex manufactured by PT Amarox Pharma Global in comparison with Efavirenz 600 mg Tablet, Sustiva ® manufactured and distributed by Bristol-Myers Squibb Company Princeton, NJ 08543 USA
| Interventions: |
The reference drug was the market available Sustiva® (Efavirenz 600 mg) film coated tablet manufactured by Bristol-Myers Squibb Company Princeton, NJ 08543 USA; Batch number : ABQ5724A1; expired date : March 2023.
The test drug was Efanex (Efavirenz 600 mg) film coated tablet manufactured by PT Amarox Pharma Global; Batch number : 08521F01G; manufacturing date : June 2021; expired date : May 2023.
In sampling day subjects took one dose of Efavirenz products of either formulation (reference or test) after an overnight fast, as per randomization scheme with 250 mL of water in sitting position.
The subjects blood samples will be taken at a certain times. |
|
| INA-RGKH7Q4 |
Complete
|
Bioequivalence study of Ezetimibe 10 mg Tablet, Ezista manufactured by PT Amarox Pharma Global in comparison with Ezetimibe 10 mg Tablet, Ezetrol ® manufactured by MSD International GmbH (Puerto Rico Branch) LLC, Puerto Rico; Packed by Schering – Plough Labo N.V., Belgium; Registered by PT Merck Sharp Dohme Pharma Tbk Pasuruan, Jawa Timur
| Interventions: |
The reference drug was the market available Ezetrol® (ezetimibe 10 mg) tablet manufactured by MSD International GmbH (Puerto Rico Branch) LLC, Puerto Rico; Packed by Schering – Plough Labo N.V., Belgium; Registered by PT Merck Sharp Dohme Pharma Tbk Pasuruan, Jawa Timur; Batch number : U019757; manufacturing date : March 2021; expired date : March 2023.
The test drug was Ezista (ezetimibe 10 mg) tablet manufactured by PT Amarox Pharma Global; Batch number : 07521H02G; manufacturing date : August 2021; expired date : July 2023.
In sampling day subjects took one dose of Ezetimibe products of either formulation (reference or test), as per randomization scheme with 250 mL of water in sitting position. |
|
| INA-46CKYFL |
Initial
|
Immunogenicity and Safety Following In-House Recombinant Hepatitis B (Bio Farma) vaccine compared to Hepatitis B (Bio Farma) ® vaccine in Indonesian Population (Phase III)
| Interventions: |
Treatment Group: In-House Recombinant Hepatitis B Bio Farma Vaccine, three doses vaccine, intramuscular injection. Control Group: Recombinant Hepatitis B (Bio Farma) Vaccine, three doses vaccine, intramuscular injection. |
|
| INA-LNARP0Q |
Complete
|
Bioequivalence study of tenofovir disoproxil fumarate/ emtricitabine 300 mg/200 mg film-coated tablet produced by PT Kimia Farma Tbk. in comparison with the comparator drug (Truvada® 300 mg/200 mg Tablet manufactured by Patheon Inc., Canada, under license of Gilead Sciences Inc., USA, imported by Gilead (Shanghai) Pharmaceutical Technology Co. Ltd., China) when administered under fasting condition in healthy subjects
| Interventions: |
The participating subjects were given orally one film-coated tablet of test drug (tenofovir disoproxil fumarate/emtricitabine 300 mg/200 mg film coated tablet produced by PT Kimia Farma Tbk.) or one tablet of comparator drug (Truvada® 300 mg/200 mg Tablet manufactured by Patheon Inc., Canada, under license of Gilead Sciences Inc., USA, imported by Gilead (Shanghai) Pharmaceutical Technology Co. Ltd., China) after an overnight fast with 200 mL of water. |
|
| INA-XMFSGW8 |
Complete
|
Bioequivalence Study of Nevirapine 200 mg Caplet Manufactured by PT. Kimia Farma Tbk in Comparison with Viramune® 200 mg Caplet Manufactured by Boehringer Ingelheim Ellas AE, Koropi, Greece for Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany
| Interventions: |
Subjects are given a single dose of 1 caplet of Nevirapine 200 mg of either formulation (test or reference) with 240 ml of water. |
|
| INA-PY7N5MD |
Recruit
|
Stop Transmisi Kusta PEP++
| Interventions: |
Rejimen PEP++ berupa kombinasi obat rifampisin dan klaritromisin |
|
| INA-TWWMH1T |
Complete
|
Bioequivalence study of levodopa 100 mg and benserazide 25 mg dispersible tablet produced by PT Dexa Medica in comparison with the comparator drug (Madopar® 125 mg Dispersible Tablet, produced by Delpharm Milano S.r.l, Italy for F. Hoffmann-La Roche Ltd., Switzerland, imported by PT Boehringer Ingelheim Indonesia, distributed by PT Roche Indonesia).
| Interventions: |
Test drug : Levodopa 100 mg and Benserazide 25 mg Dispersible Tablet Produced by PT Dexa Medica.
Reference drug: Madopar® 125 mg Dispersible Tablet, produced by Delpharm Milano S.r.l, Italy for F. Hoffmann-La Roche Ltd., Switzerland, imported by PT Boehringer Ingelheim Indonesia, distributed by PT Roche Indonesia.
The subject's blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. |
|
| INA-3MOA7O8 |
Complete
|
BIOEQUIVALENCE STUDY OF ROSUVASTATIN 20 MG FILM-COATED TABLET PRODUCED BY PT MEPROFARM IN COMPARISON WITH THE COMPARATOR DRUG (CRESTOR® 20 MG FILM-COATED TABLET)
| Interventions: |
The participating subjects were given orally one film-coated tablet of the test drug (rosuvastatin 20 mg film-coated tablet produced by PT Meprofarm) or one film coated tablet of the comparator drug (Crestor® 20 mg Film-Coated Tablet manufactured by IPR Pharmaceuticals Inc., Puerto Rico for AstraZeneca UK Limited, United Kingdom, imported by PT AstraZeneca Indonesia, Indonesia) after an overnight fast with 200 mL of water. |
|
| INA-AOW6BG7 |
Complete
|
BIOEQUIVALENCE STUDY OF ETORICOXIB 120 MG (ECOROXIB® 120) FILM-COATED TABLET MANUFACTURED BY PT DIPA PHARMALAB INTERSAINS IN COMPARISON WITH THE COMPARATOR DRUG (ARCOXIA™ 120 MG FILM-COATED TABLET)
| Interventions: |
The participating subjects were given orally one test drug (Ecoroxib® 120 mg film-coated tablet manufactured by PT Dipa Pharmalab Intersains) or one comparator drug (Arcoxia™ 120 mg Film-Coated Tablet) after an overnight fast with 200 mL of water. |
|
| INA-D683KD6 |
Complete
|
Bioequivalence Study of Bisoprolol Fumarate 10 mg (Concaprol® 10) Film-Coated Tablets Manufactured by PT IFARS Pharmaceutical Laboratories in Comparison with Concor® 10 mg Film-Coated Tablets Manufactured by PT. Merck Indonesia Tbk, Jakarta Under License From Merck KGaA, Germany
| Interventions: |
Subjects were given a single dose of 10 mg Bisoprolol of test drug or of reference drug with 240 mL of water |
|
| INA-0B7K35C |
Complete
|
Bioequivalence Study of 100 mg Kaltrofen Enteric Coated Tablet Manufactured by PT. Kalbe Farma Tbk in Comparison with 100 mg Ketoprofen Enteric Coated Tablet Manufactured by PT. Novell Pharmaceutical Laboratories, Bogor.
| Interventions: |
subjects were given a single dose of 100 mg Ketoprofen of test drug or of reference drug with 240 mL of water. |
|
| INA-BC2YXAW |
Complete
|
Bioequivalence Study of 150 mg Fluconazole Capsules Manufactured by PT. Kalbe Farma Tbk in Comparison with 150 mg Diflucan® Capsules Manufactured by PT. Pfizer Indonesia, Jakarta, Indonesia, under the authority of Pfizer Inc., New York, N.Y., USA.
| Interventions: |
Subjects were given a single dose of 150 mg fluconazole of either formulation (test or reference) with 240 mL of water |
|
| INA-P33PZRL |
Complete
|
Bioequivalence Study of 20 mg Omeprazole Delayed Release Capsules Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in Comparison with Losec 20 mg Capsules Marketed by AstraZeneca Limited, New Zealand.
| Interventions: |
The reference drug was Losec® 20 mg capsules marketed by AstraZeneca Limited, New Zealand and the test drug was Omeprazole 20 mg delayed release capsules produced by PT Etercon Pharma for PT Novell Pharmaceutical Laboratories. On the sampling day, each subject received a single oral dose of 20 mg Omeprazole, either as test or reference formulation administered along with 220 mL of water. The dose was taken at 07.00 am after an overnight fast for at least 8 hours. Water intake was allowed except for one hour before and one hour after the dose. |
|
| INA-OR87W37 |
Complete
|
Bioequivalence Study of 75 mg Oseltamivir Capsule Produced by Pt. Novell Pharmaceutical Laboratories in Comparison with Tamiflu® 75 mg Capsule Manufactured by Cenexi SAS, France, For F. Hoffmann-La Roche Ltd., Switzerland, Importad by PT. Boehringer Ingelheim Indonesia.
| Interventions: |
The reference drug was the market available Tamiflu® 75 mg Capsule batch number F0259B01; manufacturing date October 2019; expiration date October 2023. The test drug was Oseltamivir® 75 mg Capsule produced by PT Novell Pharmaceutical Laboratories, batch number D21D30 manufacturing date May 2021; expiration date May 2023. In the sampling day, each subject received a single oral dose of 75 mg Oseltamivir, either as test or reference formulation administered along with 220 mL of water. The dose was taken at 07.00 am after an overnight fast for at least 8 hours. Water intake was allowed except for one hour before and one hour after the dose. |
|
| INA-G3OW540 |
Complete
|
Dose-finding Study for AdmirSC-2f Vaccine
| Interventions: |
Intervention Name:
Biological Product: AdmirSC-2f
Intervention Description:
Two hundred forty (240) subjects will be sequentially enrolled from low dose to high dose cohort and then randomized into AdimrSC-2f vaccine group or matched placebo in a 3:1 ratio. Each enrolled subject will receive a total of 3 doses with 3-week apart by 0.5 mL intramuscular (IM) injection to the deltoid region of non-dominant arm preferably. All enrolled subjects will be follow their safety and immune response for six months. Dose level of study intervention divided into:
- Low Dose: 50 mcg of antigen with 250 mcg of Al(OH)3
- Median Dose: 100 mcg of antigen with 250 mcg of Al(OH)3
- High Dose: 100 mcg antien with 500 mcf of Al(OH)3
- Control (Placebo): 250 mcg of Al(OH)3 |
|
| INA-NQQB4Z0 |
Complete
|
Bioequivalence Study of Pantoprazole 40 mg Enteric Coated Tablets Manufactured by PT Kimia Farma in Comparison with Pantoprazole 40 mg, Pantozol® Gastro Resistant Tablets Manufactured by Takeda GmbH – Germany, Registered by PT Takeda – Indonesia.
| Interventions: |
An Open label, randomized, three-periods, three treatments, three way partial replicate in fasting condition. |
|
| INA-PQSXYHX |
Complete
|
Bioequivalence Study of 100 mg Sitagliptin Phosphate Film-Coated Tablet Manufactured by PT. Kimia Farma (Persero) Tbk. in Comparison with 100 mg Januvia® Film-Coated Tablet Manufactured by Merck Sharp & Dohme Ltd., Cramlington, England, Registered and Packed by PT. Merck Sharp Dohme Pharma Tbk, Pandaan, Indonesia
| Interventions: |
Randomized, single blind, two-period, two-treatment, two-sequence, single dose, two-way crossover study dengan periode washout period 1 minggu dalam kondisi puasa.
Pemberian Obat
Subyek diinstruksikan untuk berpuasa semalaman (8 jam) sebelum pemberian obat hingga 4 jam setelah pemberian obat. Subyek diberikan dosis tunggal 1 Tablet Sitagliptin Phosphate 100 mg baik obat uji maupun obat komparator dengan 240 ml air dalam posisi duduk. Tablet harus ditelan utuh tanpa dipecah maupun dikunyah. Subyek diminta untuk tetap berada dalam posisi tegak (berdiri atau duduk) selama 1 jam setelah pemberian obat. |
|
| INA-OL37WNF |
Complete
|
ioequivalence Study of 80 mg Gliclazide Tablet Manufactured by PT. Kimia Farma Tbk in Comparison with 80 mg Diamicron ® Tablet Manufactured by PT. Darya-Varia Laboratoria Tbk, Indonesia under license of Les Laboratories Servier, France.
| Interventions: |
Randomized, single blind, two-period, two-treatment, two-sequence, single dose, two-way crossover study dengan periode washout period 1 minggu dalam kondisi puasa.
Pemberian Obat
Subyek diinstruksikan untuk berpuasa semalaman (8 jam) sebelum pemberian obat hingga 4 jam setelah pemberian obat. Subyek diberikan dosis tunggal 1 Tablet Gliclazide 80 mg baik obat uji maupun obat komparator dengan 240 ml air dalam posisi duduk. Tablet harus ditelan utuh tanpa dipecah maupun dikunyah. Subyek diminta untuk tetap berada dalam posisi tegak (berdiri atau duduk) selama 1 jam setelah pemberian obat. Subjek diberikan 100 ml larutan glukosa 100 ml pada jam ke-1, 2, san 3 setelah pemberian obat. |
|
| INA-FQ206 |
Complete
|
BIOEQUIVALENCE STUDY OF GLIBENCLAMIDE 5 MG TABLET (LATIBET® 5 TABLET) PRODUCED BY PT IFARS PHARMACEUTICAL LABORATORIES WITH THE COMPARATOR DRUG (DAONIL® 5 MG TABLET, PT AVENTIS PHARMA, INDONESIA)
| Interventions: |
The participating subjects were given orally one film-coated tablet of the test drug (glibenclamide 5 mg tablet (Latibet® 5 Tablet) produced by PT IFARS Pharmaceutical Laboratories) and one film coated tablet of the comparator drug (Daonil® 5 mg Tablet, PT Aventis Pharma, Indonesia) after an overnight fast with 240 mL of 20% glucose solution in water according to the predetermined sequence. |
|
| INA-NYND6LT |
Complete
|
Bioequivalence study of diclofenac sodium 50 mg enteric coated tablets produced by PT Pabrik Pharmasi Zenith in comparison with the comparator drug (Voltaren® 50 mg Enteric Coated Tablet, PT Novartis Indonesia, Indonesia)
| Interventions: |
Penelitian ini dilakukan dengan memberikan kepada masing-masing subyek uji BE obat pembanding dan obat uji dengan kandungan sama pada urutan yang telah ditentukan.
Obat uji: Tablet salut enterik diclofenac sodium 50 mg produksi PT Pabrik Pharmasi Zenith.
Obat pembanding: Tablet Salut Enterik Voltaren® 50 mg.
Obat-obat tersebut diminum dengan 200 mL air. |
|
| INA-P1HLHA |
Complete
|
Bioequivalence study of fenofibrate 160 mg film-coated caplet produced by PT Guardian Pharmatama in comparison with the comparator drug (Lipanthyl Supra 160 mg Film-Coated Tablet manufactured by Recipharm Fontaine, France imported by PT Abbott Indonesia, Indonesia) when administered under fed condition in healthy subjects
| Interventions: |
Penelitian ini dilakukan dengan memberikan kepada masing-masing subyek uji BE obat inovator dan obat uji dengan kandungan sama pada urutan yang telah ditentukan.
Obat uji: Kaplet salut selaput Fenofibrate 160 mg produksi PT Guardian Pharmatama.
Obat inovator: Tablet Salut Selaput Lipanthyl Supra 160 mg.
Obat-obat tersebut diminum dengan 200 mL air. |
|
| INA-KADGW39 |
Complete
|
Bioequivalence Study of Ciprofloxacin 500 mg Caplets Manufactured by PT. Trifa Raya Laboratories in Comparison with Ciproxin® 500 mg Film-Coated Tablets Manufactured by Bayer Pharma AG, Leverkusen, Germany, Imported and Packed by PT. Bayer Indonesia.
| Interventions: |
Subjects were given a single dose of 500 mg Ciprofloxacin of test drug or of reference drug with 240 mL of water. |
|
| INA-H300DEF |
Complete
|
BIOEQUIVALENCE STUDY OF CLOPIDOGREL 75 MG FILM-COATED TABLET PRODUCED BY PT NOVELL PHARMACEUTICAL LABORATORIES IN COMPARISON WITH THE COMPARATOR DRUG (PLAVIX® 75 MG FILM-COATED TABLET MANUFACTURED BY PT AVENTIS PHARMA, INDONESIA)
| Interventions: |
Penelitian ini dilakukan dengan memberikan kepada masing-masing subyek uji BE obat inovator dan obat uji dengan kandungan sama pada urutan yang telah ditentukan. Obat uji: Tablet salut selaput clopidogrel 75 mg produksi PT Novell Pharmaceutical Laboratories. Obat inovator: Tablet salut selaput Plavix® 75 mg). Obat-obat tersebut diminum dengan 250 mL air. |
|
| INA-TPD1E |
Complete
|
BIOEQUIVALENCE STUDY OF DOXYCYCLINE 100 MG CAPSULE PRODUCED BY PT KIMIA FARMA TBK. IN COMPARISON WITH THE COMPARATOR DRUG (VIBRAMYCIN® 100 MG CAPSULE, PRODUCED BY FARMASIERRA MANUFACTURING SL., SPAIN, REGISTERED BY PFIZER HEALTHCARE IRELAND)
| Interventions: |
Subjek diberikan 100 mg doxycycline kapsul yang diproduksi oleh PT Kimia Farma Tbk atau 100 mg Vibramycin yang diproduksi oleh Farmasierra Manufacturing S.L., Spain, yang diregistrasikan oleh Pfizer Healthcare Ireland dengan air minum 200 mL setelah puasa 8 jam. Selanjutnya dilakukan periode washout 9 hari dan prosedur pemberian obat diulang untuk obat selanjutnya sesuai urutan yang telah ditentukan. |
|
| INA-XFQ6052 |
Complete
|
Bioequivalence Study of 200 mg Fenofibrate Capsules Manufactured by PT. Bernofarm in Comparison with 200 mg Lipanthyl® 200 M Capsules Manufactured by Recipharm Fontaine, France, imported and repacked by PT. Combiphar, Bandung, Indonesia.
| Interventions: |
Subjects were given a single dose of fenofibrate 200 mg of either formulation (test or reference) with 240 ml of water. |
|
| INA-MS12MM9 |
Complete
|
Bioequivalence Study of 40 mg Olmesartan Medoxomil (Olmevel) Film Coated Tablets Produced by Pt. Novell Pharmaceutical Laboratories in Comparison with Olmetec 40 mg Film Coated Tablets Manufactured by Daiichi Sankyo Europe GmbH, Germany, packed and Released by Pfizer Manufacturing Deutschland GmbH, Germany, Imported by PT. Pfizer Indonesia
| Interventions: |
The reference drug was the market available Olmetec® 40 mg Film Coated Tablets batch number DY4208; manufacturing date March 2020; expiration date February 2022. The test drug was Olmevel® 40 mg film coated caplet produced by PT Novell Pharmaceutical Laboratories, batch number D20H03 manufacturing date August 2020; expiration date August 2022. In the sampling day, each subject received a single oral dose of 40 mg olmesartan medoxomil, either as test or reference formulation administered along with 220 mL of water. The dose was taken 1t 07.00 am after an overnight fast for at least 8 hours. Water intake was allowed except for one hour before and one hour after the dose. |
|
| INA-OBD04O |
Complete
|
Uji Bioekivalensi Kapsul Aldisa® SR (Loratadin 5 mg dan Pseudoefedrin Sulfat 120 mg) Produksi PT Sanbe Farma Dibandingkan terhadap Clarityn-D® Repetabs (Loratadin 5 mg dan Pseudoefedrin Sulfat 120 mg) Produksi Schering-Plough Labo N.V. Belgia Diimpor oleh Bayer (South East Asia) PTE LTD, Singapura pada Subjek Sehat
| Interventions: |
Pengujian ketersediaan hayati loratadin dan pseudoefedrin dari Aldisa® SR yang diproduksi PT. Sanbe Farma dilakukan secara komparatif pada subjek sehat dengan desain penelitian silang lengkap menggunakan Clarityn-D® Repetabs sebagai obat komparator dan sampel plasma untuk pengujian. Obat diberikan dalam keadaan puasa dan dalam posisi duduk pada pukul 06.00-07.00 WIB dengan 220 mL air pada suhu ruang |
|
| INA-T79N |
Complete
|
Bioequivalence study of Sharox 500 (500 mg Cefuroxime) film coated caplet produced by PT. Pratapa Nirmala in comparison with Zinnat (500 mg Cefuroxime) film coated tablet produced by Glaxo Wellcome Operations, Barnard Castle, UK, imported by PT. Glaxo Wellcome Indonesia
| Interventions: |
The reference drug was the market available Zinnat® 500 mg film coated tablet batch number 747E; manufacturing date June 2019; expiration date June 2022. The test drug was Sharox® 500 mg film coated caplet produced by PT Pratapa Nirmala, batch number FC 0038 manufacturing date March 2021; expiration date March 2023. In the sampling day, subjects were took 1 Cefuroxime 500 mg products of either formulation (reference or test) with 240 mL of water in sitting position as scheduled. Water intake was permitted except during the period of 1 hour before dosing until 2 hours after dosing. |
|
| INA-WQ16ZYB |
Complete
|
Bioequivalence Study of Deferasirox 500 mg Dispersible Tablets Manufactured by PT. Bernofarm in Comparison with Exjade® 500 mg Dispersible Tablets Manufactured by Novartis Pharma Stein AG for Novartis Pharma AG, Basel, Switzerland, Imported by PT. Novartis Indonesia, Jakarta, Indonesia
| Interventions: |
subjects were given a single dose of 500 mg deferasirox of either formulation (test or reference) with 240 ml of water. Tablets should not be chewed or swallowed whole. The drug was completely dispersed by stirring in a glass of water (100 to 200 ml) until a fine suspension was obtained. Subjects administered the suspension in sitting posture. After swallowing the suspension, any residue were re-suspended in the remaining water, and swallowed all. Subjects were asked to maintain upright position (standing or sitting) for 1 hour after dosing. |
|
| INA-TK3MF5E |
Complete
|
Bioequivalence study of Etoricoxib 120 mg Film Coated Tablet, Scancox manufactured by PT Tempo Scan Pacific Tbk in comparison with Etoricoxib 120 mg Film Coated Tablet, ArcoxiaTM manufactured by Rovi Pharma Industrial Services S.A., registered and packed by PT Merck Sharp Dohme Pharma Tbk Pasuruan, East Java
| Interventions: |
Subject was given a single dose of Test product, Scancox (Etoricoxib) 120 mg Film Coated Tablet manufactured by PT. Tempo Scan Pacific, or Reference product, ArcoxiaTM (Etoricoxib) 120 mg Film Coated Tablet manufactured by Rovi Pharma Industrial Services S.A., registered and packed by PT Merck Sharp Dohme Pharma Tbk Pasuruan, East Java. Study drug administration was conducted after at least 10 hours overnight fast. Blood sample collection for each period was taken from each subject at certain time intervals post dosing. Study drug administration and blood sample collection were conducted in 2 (two) periods with wash out period of at least seven (7) days. |
|
| INA-NCZR265 |
Complete
|
Bioequivalence Study of 400 mg Moxifloxacin (Moximox) Film Coated Caplets Produced by PT. Imedco Djaja in Comparison with Avelox 400 mg Film Coated Tablets Produced by Bayer AG, Germany, imported by PT. Bayer Indonesia
|
| INA-W5R2TS5 |
Complete
|
Bioequivalence Study of 500 mg Capecitabine Film-Coated Tablets Manufactured by PT. Global Onkolab Farma in Comparison with 500 mg Xeloda® Film-Coated Tablets Manufactured by Excella GmbH & Co KG, Feucht, Germany for F. Hoffmann-La Roche Ltd, Basel, Switzerland, Imported by PT. Boehringer Ingelheim Indonesia, Bogor, Indonesia.
| Interventions: |
Subjects were given a single dose of 500 mg Capecitabine of test drug or of reference drug with 240 mL of water. |
|
| INA-TW4CQQL |
Complete
|
Bioequivalence study of Sorbicard (5 mg Isosorbide Dinitrate) sublingual tablet produced by PT. Konimex in comparison with Cedocard 5 (5 mg Isosorbide Dinitrate) sublingual tablet produced by PT. Darya-Varia Laboratoria Tbk. under license by Takeda Netherland
| Interventions: |
The reference drug was the market available Cedocard® 5 (5 mg Isosorbide Dinitrate) sublingual tablet manufactured by PT. Darya-Varia Laboratoria Tbk. under license by Takeda Netherland, batch number DX1A037, expiration date on April 2024. The test drug was Sorbicard (5 mg Isosorbide Dinitrate) sublingual tablet produced by PT. Konimex, batch number 22A (SEP21A01); manufacturing date on September 2021; expiration date on September 2023. In the morning of the sampling as scheduled, subjects took one dose of ISDN products of either formulation (reference or test), as per randomization scheme in sitting position. Subjects drank a glass of water (240 mL) 10-15 minutes before placing a sublingual tablet. Subjects put drug sublingually (under tongue) until the drug dissolved. Water intake is permitted anytime except during the period of 1 hour before dosing until 2 hours after dosing. |
|
| INA-D02FAHP |
Recruit
|
An innovative α‐calcium sulfate hemihydrate bioceramic as a potential bone graft substitute
| Interventions: |
Persiapan Preoperatif
- Pemeriksaan rutin pra-bedah minor.
- Foto.
- Pembersihan gigi (scalling).
- CT-scan pra-bedah (CBCT).
- Tanda tangan informed consent.
- Diskusikan rencana bedah minor dengan pasien atau orang tua pasien.
- Pemberian antibiotik profilaksis
Prosedur pembedahan:
Sebuah x-ray periapikal pra operasi akan diambil untuk menilai posisi gigi dan
struktur tulang di sekitarnya. Sebelum dilakukan pencabutan gigi pada kelompok
control dan eksperimen,
Prosedur pencabutan gigi atraumatik harus dilakukan dengan anestesi lokal dan
steril dengan kerusakan minimal pada jaringan lunak (gingiva) dan jaringan keras
hingga puncak tulang. Menghindari kerusakan tepi tulang alveolar marginal
biasanya dilakukan dengan menggunakan elevator. Setelah luksasi, pencabutan gigi
akan dilakukan dengan menggunakan forsep. Setelah pencabutan gigi, kuretase
tajam harus dilakukan untuk menghilangkan sisa-sisa ligamen periodontal serta
jaringan lunak lainnya. Semua ekstraksi akan dilakukan dengan hati-hati untuk
mencegah kerusakan pada dinding soket dan papila interproksimal. Soket segar
dapat α-CSH (kelompok eksperimen) atau dibiarkan tanpa diberikan biomaterial
pengganti tulang (kelompok control). Jumlah α-CSH yang akan diterapkan secara
alami akan tergantung pada ukuran soket yang perlu diisi; Menggunakan elevator
periosteal atau teknik jarum suntik, bahan dikirim ke lokasi ekstraksi dan dikemas
dengan lembut ke puncak situs. Bahan akan dicangkokkan ke dalam soket hingga 2
mm apikal ke tepi jaringan lunak; kami mengharapkan 3 gram sebagai dosis total
maksimum per pasien. Penutupan luka primer akan dicapai dengan jahitan
resorbable. Pasien akan diberikan antibiotik dan penghilang rasa sakit yang sesuai
selama 7 hari pasca operasi.
Instruksi Post-operatif:
• Makanan lunak
• Berkumur setelah makan
• Membatasi aktivitas untuk tiga hari pertama setelah bedah
Follow-up
CT-scan atau CBCT: 6 bulan setelah bedah |
|
| INA-RLEE403 |
Complete
|
BIOEQUIVALENCE STUDY OF COLCHICINE 0,5 MG TABLET PRODUCED BY PT. MAHAKAM BETA FARMA IN COMPARISON WITH THE COMPARATOR PRODUCT COLCHICINE SANDOZ® (0,5 MG COLCHICINE) TABLET PRODUCED BY TIOFARMA B.V.
| Interventions: |
Penelitian ini dilakukan dengan memberikan kepada masing-masing subyek uji BE obat inovator dan obat uji dengan kandungan sama. Obat uji: Tablet Colchicine 0,5 mg produksi PT. Mahakam Beta Farma. Obat inovator: Tablet Colchicine Sandoz® produksi TIOFARMA B.V., didaftarkan oleh SANDOZ B.V. |
|
| INA-DBQYT59 |
Complete
|
BIOEQUIVALENCE STUDY OF ATORVASTATIN 20 MG FILM COATED TABLET PRODUCED BY PT HEXPHARM JAYA LABORATORIES IN COMPARISON WITH THE COMPARATOR DRUG LIPITOR® 20 MG FILM COATED TABLET MANUFACTURED BY PFIZER PHARMACEUTICALS LLC VEGA BAJA PUERTO RICO, USA
| Interventions: |
Penelitian ini dilakukan dengan memberikan kepada masing-masing subyek uji BE obat inovator dan obat uji dengan kandungan sama pada urutan yang telah ditentukan. Obat uji: Tablet salut selaput atorvastatin 20 mg produksi PT Hexpharm Jaya Laboratories. Obat inovator: Tablet Salut Selaput Lipitor® 20 mg). Obat-obat tersebut diminum dengan 250 mL air. |
|
| INA-XA2GFG |
Complete
|
BIOEQUIVALENCE STUDY OF PIOGLITAZONE 30 MG TABLET PRODUCED BY PT ACTAVIS INDONESIA IN COMPARISON WITH THE COMPARATOR PRODUCT ACTOS® 30 MG TABLET, PT TAKEDA INDONESIA
| Interventions: |
subyek penelitian diberikan obat inovator dan obat uji dengan kandungan yang sama.
Obat Uji : Pioglitazone 30 mg tablet, manufactured by PT Actavis Indonesia.
Innovator : Actos® 30 mg Tablet, contains 30 mg of pioglitazone manufactured by PT Takeda Indonesia, |
|
| INA-FFO44FZ |
Initial
|
A Phase III, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children Aged 12-17 Years in Indonesia
| Interventions: |
Treatment Group: SARS-CoV-2 Protein Subunit Recombinant Vaccine, 2 doses of vaccine 28 days interval, intramuscular injection; Control group: Covovax – SARS-CoV-2 rS Protein (COVID-19)recombinant Vaccine, 2 doses of vaccine 28 days interval, intramuscular injection |
|
| INA-KPO7OD6 |
Complete
|
Bioequivalence study of atorvastatin 20 mg film-coated tablet produced by PT Dexa Medica for PT Beta Pharmacon in comparison with the comparator drug (Lipitor® 20 mg Film-Coated Tablet manufactured by Pfizer Manufacturing Deutschland GmbH, Germany, registered by PT Pfizer Indonesia, Indonesia)
| Interventions: |
Test drug : Atorvastatin Film-Coated Tablet 20 mg produced by PT Dexa Medica for PT Beta Pharmacon.
Reference drug Lipitor® 20 mg Film-Coated Tablet manufactured by Pfizer Manufacturing Deutschland GmbH, Germany, registered by PT Pfizer Indonesia, Indonesia
The subjects blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. |
|
| INA-W6F |
Complete
|
Bioequivalence study of Gabapentin 300 mg capsule manufactured by PT. Ifars Pharmaceutical Laboratories (Galtenix 300 mg) in comparison with Neurontin® 300 mg capsule manufactured by Pfizer Pharmaceutical LLC, Vega Baja, Puerto Rico, packaged by Pfizer Manufacturing Deutschland GmbH Bettriebsstatte Freiburg, Germany, imported by PT. Pfizer Indonesia, Jakarta, Indonesia.
| Interventions: |
Subjects were given a single dose of 300 mg gabapentin of either formulation (test or reference) with 240 ml of water |
|
| INA-Q3MRSSX |
Recruit
|
Medwell Study
| Interventions: |
Treatment group: Subject receiving regular diabetes treatment with additional Medwell digital application.
Control group: Subjects receiving regular diabetes treatment without additional Medwell digital application. |
|
| INA-NZ1GBF8 |
Complete
|
Bioequivalence study of clopidogrel 75 mg film-coated tablet produced by PT Dexa Medica for PT Beta Pharmacon in comparison with the comparator drug (Plavix® 75 mg Film Coated Tablet manufactured by PT Aventis Pharma, Indonesia, under license by Sanofi Clir SNC, France) when administered under fasting condition in healthy subjects
| Interventions: |
Test drug: Clopidogrel Film-Coated Tablet 75 mg produced by PT Dexa Medica for PT Beta Pharmacon.
Reference drug: Plavix® 75 mg Film-Coated Tablet, Manufactured by PT Aventis Pharma, Jakarta – Indonesia, Under license by Sanofi Clir SNC, Paris – France.
The subject's blood samples will be taken at a certain time. Drug administration, drink and meals for subjects, and subject activities will be standardized during the study period. |
|
| INA-ABBA4Y |
Complete
|
Bioequivalence Study of 100 mg Sitagliptin Film-Coated Tablet Manufactured by PT. Hexpharm Jaya in Comparison with 100 mg Januvia® Film-Coated Tablet Manufactured by Merck Sharp & Dohme Ltd., Cramlington, England, Registered and Packed by PT. Merck Sharp Dohme Pharma Tbk, Pandaan, Indonesia
| Interventions: |
Subjects were given a single dose of 100 mg sitagliptin film-coated tablet (either test or reference according to randomization code) with 240 mL water. |
|
| INA-B4C8H82 |
Recruit
|
Observer-Blind, Randomized, Controlled Study of Immunogenicity & Safety of SARS-Cov-2 Protein Subunit Recombinant Vaccine (Bio Farma) as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older
| Interventions: |
Treatment Group: SARS-CoV-2 Protein Subunit Recombinant Vaccine, 1 booster dose vaccine intramuscular injection; Control group: SARS-CoV-2 mRNA Pfizer Vaccine, 1 booster dose vaccine intramuscular injection |
|
| INA-HF77OE |
Complete
|
Bioequivalence Study of Diclofenac sodium 50 mg enteric-coated tablet, Nadifen 50 manufactured by PT Global Multi Pharmalab in comparison with Diclofenac sodium 50 mg enteric-coated tablet, Voltaren ® manufactured by PT Novartis Indonesia.
| Interventions: |
The reference drug was the market available Voltaren® (50 mg Diclofenac Sodium) enteric coated tablet produced by PT Novartis Indonesia, batch number ID 5893; manufacturing date on April 2021; expired date on March 2024. The test drug was Nadifen (50 mg Diclofenac Sodium) enteric coated tablet produced by PT Global Multi Pharmalab, batch number RF 08105; manufacturing date on August 2021; expired date on August 2024. In sampling day, subjects took one dose of Diclofenac Sodium products of either formulation (reference or test) with 250 mL of water according to randomization in each period in sitting position. |
|
| INA-CHKPBQ |
Complete
|
BIOEQUIVALENCE STUDY OF DIUTENSI TABLET (40 MG FUROSEMIDE) PRODUCED BY PT. KONIMEX IN COMPARISON WITH LASIX® (40 MG FUROSEMIDE) TABLET MANUFACTURED BY PT. SANOFI AVENTIS INDONESIA
| Interventions: |
The reference drug was the market available lasix® (40 mg Furosemide) tablet produced by PT Sanofi Aventis Pharma, Jakarta-Indonesia, batch number 1DN016; manufacturing date on May 2021; expiration date on April 2022. The test drug was Diutensi (Furosemide) tablet produced by PT. Konimex, batch number 1P4L9(SEP21A02); manufacturing date on 02 September 2021; expiration date on 02 September 2023. In sampling day, subjects took one dose of Furosemide products of either formulation (reference or test), as per randomization scheme with 240 ml of water in sitting position. |
|
| INA-S857CAF |
Complete
|
Bioequivalence Study of Glibenclamide 5 mg caplet produced by PT First Medipharma in comparison with Daonil (5 mg Glibenclamide) tablet produced by PT Aventis Pharma, Jakarta-Indonesia
| Interventions: |
The reference drug was the market available Daonil® (5 mg Glibenclamide) tablet produced by PT Aventis Pharma, Jakarta-Indonesia, batch number ODN008A; manufacturing date on May 2020; expiration date on April 2023. The test drug was Glibenclamide 5 mg caplet produced by PT. First Medipharma, batch number P003214; manufacturing date on 22 November 2021; expiration date on 22 November 2023. In sampling day, subjects took one dose of Glibenclamide products of either formulation (reference or test), as per randomization scheme with 240 ml of a 10% glucose solution in sitting position. |
|
| INA-YGL0K5S |
Complete
|
Bioequivalence study of Fixacep (100 mg/5 mL Cefixime) dry syrup produced by PT Pratapa Nirmala in comparison with Cefspan (100 mg/5 mL Cefixime) dry syrup produced by PT Dankos Farma for PT Kalbe Farma Tbk., under license of Astellas Pharma Inc.
| Interventions: |
The reference drug was the market available Cefspan® (100 mg/5 mL Cefixime) dry syrup produced by PT Dankos Farma for PT Kalbe Farma Tbk., under license of Astellas Pharma Inc, batch number DCEFA00192; manufacturing date on July 2020; expiration date on July 2022. The test drug was Fixacep (100 mg/5 mL Cefixime) dry syrup produced by PT Pratapa Nirmala, batch number 8AB005; manufacturing date on February 2022; expiration date on February 2024. Subjects took one dose of Cefixime products of either formulation (reference or test), as per randomization scheme with 240 ml of water in sitting position. |
|
| INA-G7MDHB7 |
Complete
|
Bioequivalence study of Renabetic (5 mg Glibenclamide) tablet produced by PT Pratapa Nirmala in comparison with Daonil (5 mg Glibenclamide) tablet produced by PT Aventis Pharma, Jakarta-Indonesia
| Interventions: |
The reference drug was the market available Daonil® (5 mg Glibenclamide) tablet produced by PT Aventis Pharma, Jakarta-Indonesia, batch number 0DN008A; manufacturing date on May 2020; expiration date on April 2023. The test drug was Renabetic (5 mg Glibenclamide) tablet produced by PT. Pratapa Nirmala, batch number FG 1561; manufacturing date on July 2021; expiration date on July 2023. Subjects took one dose of Glibenclamide products of either formulation (reference or test), as per randomization scheme with 240 ml of a 10% glucose solution in sitting position. |
|
| INA-ZG4DL9D |
Recruit
|
Vaksin Merah Putih
| Interventions: |
UNAIR Inactivated COVID-19 Vaccine (Study Product) dan Sinovac – BioFarma COVID 19 vaccine (Control) 2 dosis secara intramuscular selang 28 hari |
|
| INA-YYAG360 |
Complete
|
Bioequivalence Study of 30 mg Lansoprazole Delayed-Release Capsule Manufactured by PT IFARS Pharmaceutical Laboratories (Dobrizol Delayed-Release Capsule) in Comparison with 30 mg Takepron® Delayed-Release Capsule Manufactured by Takeda Teva Pharmaceuticals Company Limited, Japan.
| Interventions: |
Subjects were given a single dose of 30 mg lansoprazole of either formulation (test or reference) with 240 ml of water |
|
| INA-RYRAQTO |
Complete
|
Bioequivalence Study of 20 mg Omeprazole (Lokev®) Delayed-Release Capsule Manufactured by PT IFARS Pharmaceutical Laboratories in Comparison with 20 mg Losec® Capsule Manufactured by AstraZeneca AB, Soedertalie, Sweden, Imported by PT. AstraZeneca Indonesia.
| Interventions: |
subjects were given a single dose of 20 mg omeprazole of either formulation (20 mg Lokev® Delayed-Release capsule or 20 mg Losec® capsule) with 240 mL of water |
|
| INA-D4HEQMP |
Complete
|
Bioequivalence study of Zibramax (500 mg Azithromycin) film coated caplet produced by PT Guardian Pharmatama in comparison with Zithromax (500 mg Azithromycin) film coated tablet manufactured by PT Pfizer Indonesia
| Interventions: |
The reference drug was the market available Zithromax® (500 mg Azithromycin) film coated tablet manufactured by PT. Pfizer Indonesia, batch number A210081; manufacturing date on April 2021; expiration date on March 2025. The test drug was Zibramax (500 mg Azithromycin) film coated caplet produced by PT. Guardian Pharmatama, batch number T210717; manufacturing date on 21st July 2021; expiration date on July 2023. In the sampling day, subjects took 1 dose of Azithromycin products of either formulation (reference or test) with 240 mL of water in sitting position as scheduled. Water intake was permitted except during 1 hour before dosing until 2 hours after dosing. |
|
| INA-F0M6LGX |
Complete
|
Bioequivalence study of Sorbicard (5 mg Isosorbide Dinitrate) sublingual tablet produced by PT. Konimex in comparison with Cedocard 5 (5 mg Isosorbide Dinitrate) sublingual tablet produced by PT. Darya-Varia Laboratoria Tbk. under license by Takeda Netherland
| Interventions: |
The reference drug was the market available Cedocard® 5 (5 mg Isosorbide Dinitrate) sublingual tablet manufactured by PT. Darya-Varia Laboratoria Tbk. under license by Takeda Netherland, batch number DX1A037, expiration date on April 2024. The test drug was Sorbicard (5 mg Isosorbide Dinitrate) sublingual tablet produced by PT. Konimex, batch number 22A (SEP21A01); manufacturing date on September 2021; expiration date on September 2023. In the morning of the sampling as scheduled, subjects took one dose of ISDN products of either formulation (reference or test), as per randomization scheme in sitting position. Subjects drank a glass of water (240 mL) 10-15 minutes before placing a sublingual tablet. Subjects put drug sublingually (under tongue) until the drug dissolved. Water intake is permitted anytime except during the period of 1 hour before dosing until 2 hours after dosing. |
|
| INA-W5ML2T2 |
Initial
|
Phase 3 Inhaled Novaferon Study in Hospitalized Patients With Moderate to Severe COVID-19 (NOVATION-1)
| Interventions: |
The selected dose regimen is 20 μg aerosolized Novaferon or placebo, administered using a vibrating mesh nebulizer, twice per day with an interval between doses of at least 4 hours, for 10 days, or until discharged, if discharge occurs within 10 days. Each 20 μg dose of Novaferon (2 x 1 mL vials) or placebo will be administered to patients by nebulizer for approximately 10 minutes.
The supplied matching placebo formulation is identical in physical appearance to the active formulation and contains the same inactive ingredients. The study treatment/placebo will be given in conjunction with SOC treatment(s) |
|
| INA-R5752S9 |
Recruit
|
Immunogenicity & Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted with Alum+CpG 1018 Compared to Registered Covid-19 Vaccine (Covovax – Protein Subunit Vaccine) in Healthy Populations Aged 18 Years and Above in Indonesia (Phase III)
| Interventions: |
Treatment Group: SARS-CoV-2 Protein Subunit Recombinant Vaccine, 2 doses of vaccine 28 days interval, intramuscular injection
Control group: Covovax – SARS-CoV-2 rS Protein (COVID-19)recombinant Vaccine, 2 doses of vaccine 28 days interval, intramuscular injection |
|
| INA-P7NSA4P |
Recruit
|
A Phase 2, Observer-Blind, Randomized, Placebo-Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted with Alum+CpG 1018 in Healthy Populations Aged 18 Years and Above in Indonesia
| Interventions: |
Treatment Group: SARS-CoV-2 Protein Subunit Recombinant Vaccine, 2 doses of vaccine with 28 days interval, intramuscular injection
Control group: Placebo, 2 doses of placebo with 28 days interval, intramuscular injection |
|
| INA-H0MOBSZ |
Complete
|
: Bioequivalence study of 100 mg sitagliptin film-coated tablet produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals in comparison with the comparator drug (Januvia® 100 mg Film-Coated Tablet manufactured by Merck Sharp & Dohme Ltd., England, registered and packaged by PT Merck Sharp Dohme Pharma Tbk., Indonesia.
| Interventions: |
Test drug : Sitagliptin film coated tablet 100 mg produced by PT Dexa Medica.
Reference drug : Januvia® 100 mg Film-Coated Tablet, Manufactured by Merck harp & Dohme Ltd., England, Registered and Packaged by PT Merck Sharp Dohme Pharma TBK., Indonesia.
The subjects blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. |
|
| INA-ZBMDZ7C |
Initial
|
Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy (MetLep Trial)
| Interventions: |
Uji klinik fase 2, acak (1:1), double-blind, terkontrol. Metformin sebagai obat uji dibandingkan dengan plasebo. Subyek menerima pengobatan standar selama 48 minggu, yaitu dengan multidrug therapy (MDT yang terdiri atas dapson, klofazimin, dan rifampisin). Metformin/plasebo dikombinasikan dengan MDT selama 24 minggu pertama. Follow-up dilakukan setelah selesai intervensi metformin/plasebo selama 24 minggu. |
|
| INA-ZN6M5MG |
Recruit
|
Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria
| Interventions: |
Sanaria® PfSPZ Vaccine: Radiation attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites
(PfSPZ) administered by direct venous inoculation (DVI). Normal Saline (0.9% NaCl): The placebo control administered by DVI. Sanaria® PfSPZ-CVac: Infectious, aseptic, purified, cryopreserved PfSPZ (Sanaria® PfSPZ Challenge) administered by DVI to individuals taking chloroquine (CQ) chemoprophylaxis. Normal Saline (0.9% NaCl): The placebo control administered by DVI to individuals taking CQ chemoprophylaxis. Diluent. The diluent for PfSPZ Vaccine and PfSPZ Challenge will be phosphate buffered saline (PBS) with 1% human serum albumin. |
|
| INA-EPQFKH4 |
Complete
|
Bioequivalence study of Diutensi tablet (40 mg Furosemide) produced by PT. Konimex in comparison with Lasix® (40 mg Furosemide) tablet manufactured by PT. Sanofi Aventis Indonesia
| Interventions: |
The reference drug was the market available Lasix® (40 mg Furosemide) tablet manufactured by PT. Sanofi Aventis Indonesia, batch number 1DN016, expiration date on April 2024. The test drug was Diutensi tablet (40 mg Furosemide) produced by PT. Konimex, batch number F1P4L9(SEP21A02); manufacturing date on September 2021; expiration date on September 2023. |
|
| INA-ME8QS7 |
Complete
|
Bioequivalence Study of Ticagrelor 90 mg Film-Coated Tablets Manufactured by PT. Hexpharm Jaya for PT. Kalbe Farma Tbk in Comparison with Brilinta® 90 mg Film-Coated Tablets Manufactured by AstraZeneca AB, Sweden, Packed and Released by AstraZeneca Pharmaceutical Co., Ltd, China, Imported by AstraZeneca Indonesia, Bekasi, Indonesia.
| Interventions: |
Subjects were given a single dose of Ticagrelor 90 mg Film-Coated Tablets or Brilinta® 90 mg Film-Coated Tablets under fasted condition. The drug was administered with 240 mL water. |
|
| INA-LPAEZM |
Complete
|
Bioequivalence study of 1000 mg Metformin HCl extended release caplet manufactured by PT. Hexpharm Jaya (Nevox XR 1000 mg Caplet) for Formula A and Formula B in comparison with 1000 mg Glucophage® XR extended release tablet manufactured by Merck Sante SAS, France, imported by PT. Merck Indonesia Tbk., Jakarta
| Interventions: |
Subjects were given a single dose of 1 extended release caplet of the test drug (Nevox XR 1000 mg Caplet formula A or formula B) or 1 extended release tablet of the reference drug (Glucophage® XR extended release 1000 mg Tablet) under fasted condition. The drug was administered with 240 ml of 20% glucose solution in water. |
|
| INA-XLLSX2Z |
Complete
|
Bioequivalence study of Levazide® tablet (100 mg Levodopa and 25 mg Benserazide HCL) produced by PT Pyridam Farma in comparison with Madopar® 125 mg T tablet (100 mg Levodopa and 25 mg Benserazide HCL) manufactured by Roche Pharma AG, 79630 Grenzach-Whylen
| Interventions: |
The reference drug was the market available Madopar® 125 mg T tabletten (100 mg Levodopa and 25 mg Benserazide HCL) manufactured by Roche Pharma AG, 79630 Grenzach-Whylen, batch number M3211M1, expiration date on December 2024. The test drug was Levazide® tablet (100 mg Levodopa and 25 mg Benserazide HCL) produced by PT Pyridam Farma, batch number PELEV001.02-05; manufacturing date on October 2021; expiration date on October 2023 |
|
| |
Initial
|
NA
| Interventions: |
Pemberian obat uji dilakukan setelah puasa minimal 10 jam semalam. |
|
| INA-HAWRFA8 |
Recruit
|
BDB-001
| Interventions: |
a. Treatment group: conventional treatment + BDB-001 Injection
b. Control group: conventional treatment |
|
| INA-N2ZX642 |
Initial
|
-
| Interventions: |
Treatment Arm 1 Bevagen/Bevacizumab(Once each cycle for 6 cycles)+ Oxaliplatin (Once each cycle for 6
cycles) + Capecitabine (q.d. 14 days each cycle for 6 cycles)
Treatment Arm 2 Avastin (Once each cycle for 6 cycles) + Oxaliplatin(Once each cycle for 6 cycles) +
Capecitabine (q.d. 14 days each cycle for 6 cycles) |
|
| INA-OYBE2M0 |
Initial
|
Proxalutamide
| Interventions: |
Treatment Arm 1 : Proxalutamide 300 mg (q.d 14 days) + SoC selama 14 hari
Treatment Arm 2 : Placebo (q.d 14 days)+ SoC for 14 days selama 14 hari |
|
| INA-MNL47N9 |
Recruit
|
ARCoV-005
| Interventions: |
Vaksin Aktif ARCoV : Placebo/ Normal Saline dengan perbandingan 1:1 |
|
| INA-WCMM |
Complete
|
Clinical Trials to Assess Safety and Efficacy of DWRX2003 Combination With Remdesivir in Moderate to Severe COVID-19 Patients.
| Interventions: |
Arm 1 = Niclosamide 432mg (i.m.) + Remdesivir
Arm 2 = Niclosamide 960mg (i.m.) + Remdesivir
Arm 3 = Placebo (i.m.) + Remdesivir |
|
| INA-EF623 |
Recruit
|
Dose-finding Study for AdmirSC-2f Vaccine
| Interventions: |
Intervention Name:
AdmirSC-2f (Biological)
Intervention Description:
Each enrolled subject will receive a total of 3 doses with 3-week apart by 0.5 mL intramuscular (IM) injection to the deltoid region of non-dominant arm preferably. Dose level of study intervention are divided into:
- Low Dose: 50 mcg of antigen with 250 mcg of Al(OH)3
- Median Dose: 100 mcg of antigen with 250 mcg of Al(OH)3
- High Dose: 100 mcg antien with 500 mcf of Al(OH)3
- Control (Placebo): 250 mcg of Al(OH)3 |
|
| INA-R2CYB06 |
Complete
|
Bioequivalence study of Pysolan (30 mg Lansoprazole) delayed release capsule produced by PT Pyridam Farma in comparison with Takepron (30 mg Lansopazole) delayed release capsule manufactured by Takeda Pharmaceutical Company Ltd.
| Interventions: |
The reference drug was the market available Takepron (30 mg Lansopazole) delayed release capsule manufactured by Takeda Pharmaceutical Company Ltd, batch number AA1111 expiration date on February 2022. The test drug was Pysolan (30 mg Lansoprazole) delayed release capsule produced by PT Pyridam Farma, batch number PEPYS002.01-01; manufacturing date on October 2021; expiration date on October 2023. |
|
| INA-W48WO2 |
Complete
|
Bioequivalence study of cefixime 100 mg/5 mL dry syrup produced by PT Dexa Medica in comparison with the comparator drug (Suprax® 100 mg/5 mL Powder for Oral Suspension, Odan Laboratories Ltd., Canada)
| Interventions: |
Test drug : Cefixime 100 mg/5 mL dry syrup produced by PT Dexa Medica.
Reference drug : Suprax® 100 mg/5 mL Powder for Oral Suspension, Odan Laboratories Ltd., Canada, Imported by PT Dexa Medica.
The subjects blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. |
|
| INA-K8ARASK |
Complete
|
Bioequivalence Study of Erlotinib 150 mg Film-Coated Tablets Manufactured by PT. Global Onkolab Farma in Comparison with Tarceva® 150mg Film-Coated Tablets Manufactured by Roche SpA, Segrate, Italy, Imported By PT. Boehringer Ingelheim Indonesia.
| Interventions: |
Subjects were given a single dose of 1 film-coated tablet of the drug (Erlotinib 150 mg film-coated tablets or Tarceva® 150 mg film-coated tablets) under fasted condition. The drug was administered with 240 mL water. |
|
| INA-TPW9FSF |
Complete
|
Implant 1 Batang Etonogestrel
| Interventions: |
Kesulitan dalam pencarian subjek yang bebas hormonal selama 3 bulan. |
|
| INA-CY27H |
Complete
|
BIOEQUIVALENCE STUDY OF NEBIVOLOL 5 MG TABLET PRODUCED BY PT YARINDO FARMATAMA IN COMPARISON WITH NEBILET (NEBIVOLOL 5 MG) TABLET MANUFACTURED BY BERLIN-CHEMIE AG, GERMANY, IMPORTED BY PT. MENARINI INDRIA LABORATORIES - INDONESIA
| Interventions: |
The reference drug was the market available Nebilet® 5 mg tablet produced by Berlin-Chemie AG, Germany, imported by PT. Menarini Indria Laboratories - Indonesia, batch number 02705B manufacturing date May 2020; expiration date May 2023. The test drug was Nebivolol 5 mg tablet produced by PT Yarindo Farmatama, batch number 13210621; manufacturing date June 2021; expiration date June 2023. |
|
| INA-GYTE3LR |
Recruit
|
Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018
| Interventions: |
Randomized, observer-blind, controlled, prospective intervention study.
Test product: SARS-CoV-2 protein subunit recombinant vaccine, 2 doses 28 days interval, 0.5mL each dose
Comparator: COVID-19 vaccine Bio Farma (inactivated vaccine), 2 doses 28 days interval, 0.5mL each dose |
|
| INA-ZL7S4P |
Recruit
|
Uji Diagnostik Alat Skrining Covid-19 berbasis Saliva "Gumnut/AptameX"
| Interventions: |
Penelitian ini menggunakan DNA aptamer berbasis point of core dengan dasar diagnostik yang lebih murah, cepat, dan akurat sebagai solusi skrining pada populasi yang terpajan virus COVID-19. DNA aptamer sequences akan berikatan dengan protein SARS-COV 2 yang mana telah di publikasikan tahun ini oleh 2 grup peneliti di China dengan menggunakan kit yang akan digunakan pada penelitian ini. DNA aptamer memanfaatkan struktur spektroskopi nano partikel yang bertransisi dari kondisi aggregasi dan disagregasi sebagai suatu sinyal transduksi mekanis pada kolorimetri ataupun lateral flow assays. |
|
| INA-SN7GB2 |
Complete
|
BIOEQUIVALENCE STUDY OF CANDESARTAN CILEXETIL 8 MG + AMLODIPINE BESYLATE 5 MG TABLET PRODUCED BY PT PRATAPA NIRMALA IN COMPARISON WITH UNISIA® (CANDESARTAN CILEXETIL 8 MG + AMLODIPINE 5 MG) TABLET PRODUCED BY TAKEDA PHARMACEUTICAL COMPANY LTD., HIKARI, JAPAN
| Interventions: |
Test drug: Candesartan cilexetil 8 mg + Amlodipine besylate 5 mg tablet produced by PT Pratapa Nirmala
Reference drug: Unisia® (Candesartan cilexetil 8 mg + Amlodipine 5 mg) tablet produced by Takeda Pharmaceutical Company Ltd., Hikari, Japan. |
|
| INA-R99GO63 |
Recruit
|
Uji Klinis Suplementasi Probiotik pada Psoriasis Vulgaris
| Interventions: |
1.Pada kelompok perlakuan diberi intervensi berupa pemberian terapi standard dan probiotik L.plantarum IS 10605 sejumlah 2x10pangkat10 CFU selama 12 minggu.
2.Pada kelompok plasebo diberi intervensi berupa pemberian terapi standard dan plasebo 2x1 sachet selama 12 minggu.
3.Mengukur derajat keparahan penyakit dengan Psoriasis Area and Severity Index (PASI), kadar serum sitokin TNF-α, IL-17, IL-10, dan Foxp3,serta memeriksa profil mikrobiota usus dari sampel feses sebelum dan sesudah perlakuan.
4.Kelompok kontrol sehat tidak diberi perlakuan. Dilakukan pengambilan sampel feses untuk pemeriksaan profil mikrobiota usus. |
|
| INA-F7MRQNA |
Recruit
|
A Global, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Adults Aged 18 Years and Older
| Interventions: |
Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) dan Blank Preparation of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) |
|
| INA-HB8C9XD |
Recruit
|
A global phase III clinical trial of recombinant COVID-19 vaccine (Sf9 cells) in adults aged 18 years and older
| Interventions: |
Recombinant COVID-19 vaccine (Sf9 cells) dan Plasebo |
|
| INA-ZTGW21 |
Initial
|
A Phase I, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Populations Aged 18 Years and Above in Indonesia
| Interventions: |
This trial is observer blinded, comparative, randomized, phase I. Approximately 60 subjects will be recruited in this study. The safety and immunogenicity result of the Phase I study will determine the continuation of the next phase clinical trial.
The vaccine candidate (SARS-CoV-2 protein subunit recombinant vaccine) will be compared to active control. The regimen of the investigational product is 0.5 ml injected 50 μg in three dose-regimen (for all subjects) with 28 days apart between doses. Antibody testing after each dose will be conducted to evaluate the immunogenicity profile after vaccination. |
|
| INA-TH0Z9M |
Initial
|
Safety Profile of BCG vaccine vial (Bio Farma)
| Interventions: |
This trial is bridging study, observer blinded, comparative, randomized study.
Approximately 220 subjects will be recruited, 110 subjects are the investigational arm (BCG vaccine vial) and 110 subjects are the active comparator arm (BCG vaccine ampoule). |
|
| INA-FHLR49W |
Initial
|
Bioequivalence study of Azithromycin 500 mg film coated caplets manufactured by PT Promedrahardjo Farmasi Industri in comparison with Azithromycin 500 mg Zithromax film coated tablets manufactured by PT Pfizer Indonesia; under licensed by Pfizer Inc, New York, N.Y., USA
| Interventions: |
Selambat-lambatnya 7 hari sebelum dan selama masa studi, subyek tidak diperbolehkan mengkonsumsi obat apapun, temasuk OTC, Suplemen kesehatan dan/atau jamu/Obat herbal. Dalam keadaan darurat, penggunaan obat non-studi harus dilaporkan (dosis dan waktu pemberian) kepada Dokter Penanggung Jawab. Merokok, alkohol dan makanan atau minuman yang mengandung xanthin, dan jus buah tidak diperbolehkan dalam waktu 24 jam sebelum dan selama seluruh hari pengambilan sampel pada setiap periode. |
|
| INA-GO0HLGB |
Initial
|
Immunogenicity and Safety Study of Half and Full Dose of Heterologous and Homologous COVID-19 Vaccine Booster in Adult Subjects in Indonesia
| Interventions: |
• Comirnaty® (Pfizer Vaccine) 0.3 ml intramuscularly
• Comirnaty® (Pfizer Vaccine) 0.15 ml intramuscularly
• ChAdOx1-S (AstraZeneca Vaccine) 0.5 ml intramuscularly
• ChAdOx1-S (AstraZeneca Vaccine) 0.25 ml intramuscularly
• CoronaVac® (Sinovac Vaccine) 0.5 ml intramuscularly |
|
| INA-DC4CNNS |
Complete
|
Modulasi Gut Microbiota dan Perbaikan Status Gizi pada Balita Gizi Kurang di Yogyakarta dengan Intervensi Jelly Candy Probiotik Lactobacillus plantarum Dad-13
| Interventions: |
Kelompok Probiotik : Permen jeli L. plantarum Dad-13 (Komposisi: gelatin sapi, sukrosa, glucose syrup, air, skim milk dengan L. plantarum Dad-13)
Kelompok placebo: Permen jeli tanpa L. plantarum Dad-13 (Komposisi: gelatin sapi, sukrosa, glucose syrup, air, skim milk tanpa L. plantarum Dad-13 |
|
| XW2N3R |
Initial
|
Vaksin Merah Putih UNAIR
| Interventions: |
UNAIR Inactivated COVID-19 Vaccine (Study Product) dan Sinovac – BioFarma COVID19 vaccine (Control) 2 dosis secara intramuscular selang 28 hari |
|
| INA-KFQZKG |
Complete
|
The Evaluation of the Effects of Implementing Tailored Care Program on Patients with Diabetes in Indonesia
| Interventions: |
The main study was a randomized controlled trial (RCT) to test and evaluate the tailored care for patients with diabetes in Indonesia.
Design
A single-blinded repeated measure RCT with two group pre-test and post-test design was used to test a tailored care intervention program for patients with diabetes in Indonesia. This design is particularly relevant where a new intervention as a tailored care program was compared to a routine treatment or a comparative intervention. Design for RCT is the gold standard to minimize bias through the process of random assignment and blinding. Moreover, the RCT as an intervention design was selected to test the effectiveness of the tailored care intervention. The intervention program is set at helping the participants acquire physiological outcomes, self-management, self-care activity, risk assessment for diabetes complications and psychosocial outcomes in three months of data collection after the intervention program. The main goals of the study were focused on after receiving three months tailored care program participant showed significant improvements from pre to post-intervention programs in improving the physiological outcomes (HbA1c, body mass index, blood pressure, triglyceride, blood glucose, triglyceride glucose index and cholesterol levels), diabetes self-management, self-care activity, risk assessment for diabetes complication, quality of life and diabetes-related distress.
Randomization
Lists of names of potential respondents who perform health checks routinely in primary health cares, have complete laboratory data especially HbA1c from September-December, are collected then randomized using a computer (Excel program) to avoid selection bias. After randomization, respondents were divided into two groups, intervention and control groups.
Each address of respondent was also collected so, they could be tracked in each area where they lived. Furthermore, the researcher went to each respondent's house for inviting participant candidate to participate in the study. All respondents agreed to participate in the study because they would receive free medical tests such as blood sugar level, blood pressure, weight, height, cholesterol and triglycerides every month during the visit or follow up activity.
Blinding
In this study, all participants are blind to the allocation. It avoids those elements that have potentially influenced the outcomes from allocations. Participants were also blinded as to their group assignment to avoid their expectations for that treatment. It has been confirmed that there was no communication between participants in the intervention and the control group.
The participants in control groups in this study receive d routine care from staff in a clinical setting. On the other hand, the intervention group received a tailored care program in the community setting.
Preparation before tailored care program for diabetes implemented
1. Apperception related to all processes and procedures to be carried out in the study with two research assistants.
2. Research assistants attended an apperception about how to use the tailored care and practice skills for managing groups.
3. After apperception, facilitators were supported to deliver the intervention
Application of the tailored care program for diabetes
1. Brief deducted teaching
Firstly, it is necessary to hold a lay seminar attended by patients with diabetes. This seminar was filled with speakers who are experts in their fields such as a nurse, a doctor, and a nutritionist. The lay seminar contains ways for patients to perform self-management to maintain their blood glucose still stable while at home.
2. Assessment for self-management level and risk of cardiovascular disease (CVD) among patients
After didactic teaching was completed, the nurse conducts an assessment to determine the level of patient self-management, how many the percentages of patients’ risk of complication. The risk report was personalized to describe individual complication risk then patients with a high risk of complications treated by the sub-specialist physicians. Patients were divided into groups for brainstorming the difficulties on glycaemic target and specific target behaviour.
3. Brainstorming among patients to share their difficulty on glycaemic targets and specific target behaviour
Programs in the form of support groups between diabetes patients was a good media for patients to share their experiences with each other regarding their lifestyle for blood sugar control. This support group is accompanied by a facilitator to ensure information exchange among patients are still safe and there is no risk of malpractice when patients apply it themselves while at home.
4. Making a list of patients’ needs then rank the priorities
The experience they gained from the discussion in the support group became their literature in choosing which invention was the most appropriate to keep their blood glucose stable while at home.
5. Setting a goal and writing action
The goal of the patient that wanted to be achieved and the intervention plan that the patient has chosen can be written on a monitoring book that they have. Monitoring books can be read by health workers when patients with diabetes carry out health control routinely every month at primary health care.
6. Follow-up
Each report in the monitoring book was valuable data for hospitals or health facilities to determine the most appropriate interventions for patients in the future.
7. Report of goals attempt
After three months, participants report their goal attempt, where a goal has been partially achieved or not achieved. Moreover, the outcome evaluation (physical, self-management, psychosocial, self-care activity, risk assessment for diabetes complication) was also evaluated. |
|
| INA-BZLNAF |
Initial
|
Uji Klinik Fase III Acak Terbuka membandingkan Pemberian Terapi Tambahan Bamlanivimab - Etesivimab pada Standard of Care dibandingkan dengan Standard of Care Pada Pasien Covid -19 Derajat Ringan Sedang
| Interventions: |
Pemberian tamabahan antibodi monoklonal yaitu Bamlanivimab 700 mg dan Etesevimab 1400 mg dosis tunggal kepada Favipiravir 2 x 1600 mg hari pertama, dilanjutkan 2 x 600 mg sampai hari ke 5 dibandingkan saja dengan Favipiravir 2 x 1600 mg hari pertama, dilanjutkan 2 x 600 mg sampai hari ke 5 |
|
| INA-K4EBD14 |
Recruit
|
Uji Klinik Tocilizumab Balitbangkes - RS Dustira-UNJANI
| Interventions: |
Tocilizumab 8mg/kgBB selama 2 hari dan kelompok kontrol. |
|
| INA-N8OBX96 |
Initial
|
Uji Klinik Tocilizumab Balitbangkes - RSUP Sardjito
| Interventions: |
Adjunctive Treatment of 8mg/kgBW atau 4mg/kgBW of Tocilizumab |
|
| INA-ZAEQA4L |
Initial
|
Riset Klinis Efikasi IVIG Balitbangkes-RS Kandou
| Interventions: |
Kel 1. Pengobatan Standard Covid-19 sesuai panduan praktek klinik COVID-19 RSUP Prof. dr. R.D. Kandou
Kel 2. Pengobatan Standar + IVIG dosis 0,3 g/kgBB selama 3 hari
Kel 3. Pengobatan Standar + IVIG dosis 0,5 g/kgBB selama 3 hari |
|
| INA-K46P2P |
Complete
|
PERBANDINGAN EFEK REMIFENTANIL INTRAVENA 1 µg/kgBB DENGAN 0,5 µg/kgBB DIIKUTI RUMATAN 0,1 µg/kgBB/MENIT TERHADAP PERUBAHAN TEKANAN DARAH DAN LAJU NADI SAAT INTUBASI ENDOTRAKEAL: UJI ACAK TERKENDALI
| Interventions: |
Subjek penelitian berjumlah 35 pasien yang terdiri dari kelompok remifentanil bolus 1 μg/kgBB (R1) dan kelompok remifentanil bolus 0,5 μg/kgBB (R2).
Kelompok R1 diberikan remifentanil bolus 1 μg/kgBB, dilanjutkan rumatan 0,1 μg/kgBB/menit sebelum tindakan laringoskopi dan intubasi endotrakeal. Kelompok R2 diberikan remifentanil bolus 0,5 μg/kgBB, dilanjutkan rumatan 0,1 μg/kgBB/menit. Pemberian remifentanil bolus kedua kelompok dilakukan selama 60 detik, yang langsung dilanjutkan dengan dosis rumatan 0.1 μg/kgBB/menit menggunakan syringe pump. Selanjutnya diberikan propofol bolus 2 mg/kgBB selama 30 detik. Setelah tertidur, pasien diberikan atrakurium 0,5 mg/kgBB secara intravena.
Jika laju nadi turun sampai < 40 x/menit, diberikan sulfas atropine 0,5 mg IV. Jika tekanan darah turun lebih dari 30%, diberikan vasopressor (ephedrine 5-10 mg). Rumatan anestesi menggunakan isofluran dan fraksi O2 dalam udara 50% dengan laju aliran 3 L/menit.
Pengukuran hemodinamik mencakup tekanan darah sistolik, tekanan darah diastolik, dan laju nadi yang dilakukan 2 menit setelah induksi (T1), 1 menit setelah intubasi (T2), dan dilanjutkan pada menit ke 3 dan 5 setelah intubasi (T3 dan T4).
Pendataan karakteristik demografi pasien mencakup usia, indeks massa tubuh dan status fisik ASA. |
|
| INA-GDN05DZ |
Recruit
|
International study on COVID-19 Vaccine to assess Immunogenicity, Reactogenicity and Efficacy (InVITE)
| Interventions: |
Tidak ada intervensi |
|
| INA-QPSF79H |
Complete
|
PERBANDINGAN PEMBERIAN FENTANYL 2 µg/KGBB BOLUS TUNGGAL DENGAN REMIFENTANIL 1 µg/KGBB SAAT INDUKSI DILANJUTKAN RUMATAN 0,1 µg/KGBB/MENIT TERHADAP KEJADIAN MUAL MUNTAH PASCABEDAH ODONTEKOMI
| Interventions: |
Pemberian fentanyl 2 µg/kgBB bolus tunggal dibandingkan dengan remifentanil 1 µg/kgBB saat induksi dilanjutkan dengan rumatan 0,1 µg/kgBB/menit pada kelompok 2 terhadap kejadian mual muntah pascabedah odontektomi.
Pasien dibagi dalam dua kelompok, yaitu kelompok fentanyl 2 µg/kgBB bolus tunggal dan kelompok remifentanil 1 µg/kgBB diberikan saat induksi dilanjutkan rumatan 0,1 µg/kgBB/menit selama intraoperasi, masing-masing 22 sampel.
Pada saat induksi anestesi umum diberikan 0,1 ml/kgBB dari obat yang sudah disediakan dalam spuit 10 ml menggunakan syringe pump dalam 1 menit dilanjutkan dengan propofol 2 mg/kgBB IV, atrakurium 0,5 mg/kgBB IV, kemudian dilakukan intubasi dengan pipa endotrakeal spiral. Untuk rumatan anestesi volatile sevofluran dan gas N2O : O2 50% dilanjutkan menggunakan obat yang telah disediakan dalam spuit 20 ml dengan rumatan 0,12 ml/kgBB/jam menggunakan alat syringe pump. Pasien diberikan antinyeri Parasetamol 20 mg/kgBB intravena 15 menit sebelum operasi selesai dan reverse diberikan antikolinesterase neostigmin.
Selama operasi dilakukan pencatatan tekanan darah, nadi, saturasi oksigen. Pascabedah dilakukan pencatatan tekanan darah, nadi, saturasi oksigen, skala mual muntah.
Pemantauan untuk kejadian mual muntah dilakukan observasional pencatatan setiap 30 menit dalam waktu 2 jam pascabedah di Ruangan Pemulihan. Untuk pasien yang mengalami kejadian mual muntah diberikan rescue Ondansentron 4 mg. |
|
| INA-MCCLRWE |
Recruit
|
Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia
|
| INA-D5T23Q7 |
Initial
|
UJI KLINIK JAMU SAMBILOTO PADA PASIEN COVID-19 2021 (UKIJASAMVID 2021)
| Interventions: |
METODE INTEVENSI:
Uji klinik terkontrol acak tersamar ganda
• Kelompok pembanding
Subjek kelompok ini mendapatkan terapi standar untuk COVID-19 ditambah dengan plasebo dosis 3 x 4 kapsul setelah makan, berjarak 2 (dua) jam dari terapi standar. Intervensi dilakukan selama 10 hari atau sampai subjek sudah diperbolehkan pulang dari RS (jika kurang dari 10 hari).
• Kelompok intervensi.
Subjek mendapatkan terapi standar untuk COVID-19 ditambah dengan Jamu ekstrak sambiloto dosis 3 x 4 kapsul pagi dan sore setelah makan , berjarak 2 (dua) jam dari terapi standar. Jamu ekstrak sambiloto tersebut diberikan setiap hari selama 10 hari atau sampai subjek sudah diperbolehkan pulang dari RS (jika kurang dari 10 hari).
Terapi standar untuk kasus sedang adalah obat yang digunakan untuk penderita Covid 19 gejala sedang yang berlaku di RSUD Bung Karno (sesuai PPK RSUD Bung Karno).
BAHAN UJI:
Jamu ekstrak sambiloto dan plasebo dibuat dan dikemas oleh PT. Industri Jamu Borobudur Indonesia. Jamu ekstrak sambiloto yang digunakan bermerk SAMBIO®. Sediaan jamu berupa kapsul berisi ekstrak sambiloto 330 mg. Kemasan berupa botol berisi 60 kapsul. Produk uji disimpan di gudang farmasi Rumah Sakit Bung Karno dengan suhu optimal yaitu kurang dari 25 derajat celcius dan di tempat yang kering.
KONDISI SUBYEK:
Pasien baru yang terdiagnosis Covid-19 dengan gejala sedang yang dirawat di instalasi rawat inap RSUD Bung Karno Surakarta |
|
| INA-2SYO8K6 |
Recruit
|
Dexamethasone on Cerebral Toxoplasmosis Study (De-TOX Study)
| Interventions: |
Deksametason 20 mg (4cc) dibandingkan dengan plasebo (4 cc larutan NaCl 0.9%) selama 7
hari sebagai tambahan terapi antiparasit dan atau antiretroviral untuk pasien HIV dengan toxoplasma serebral. |
|
| INA-EODLQCG |
Initial
|
HARVEST (Rifampisin oral dosis tinggi untuk memperbaiki luaran pada pasien dewasa dengan meningitis tuberkulosis
| Interventions: |
HARVEST merupakan uji klinik fase 3 terkontrol, multisenter, dan tersamar ganda yang bertujuan untuk menilai apakah rifampisin dosis tinggi dapat memperbaiki luaran 6 bulan dibandingkan dengan rifampisin dosis standar.
Subyek akan dilakukan randomisasi 1:1 dan dibagi ke dalam dua kelompok: 1. Kelompok dengan rifampisin dosis tinggi (Rifampisin oral ~35 mg/kg/hari selama 8 minggu) dikombinasikan dengan standard HZE dan 2. Kelompok dengan rifampisin dosis standar (Rifampisin oral ~10 mg/kg/hari selama 8 minggu) dikombinasikan dengan standar dosis HZE. |
|
| INA-MY0NWNW |
Initial
|
HARVEST (Rifampisin oral dosis tinggi untuk memperbaiki luaran pada pasien dewasa dengan meningitis tuberkulosis
| Interventions: |
HARVEST merupakan uji klinik fase 3 terkontrol, multisenter, dan tersamar ganda yang bertujuan untuk menilai apakah rifampisin dosis tinggi dapat memperbaiki luaran 6 bulan dibandingkan dengan rifampisin dosis standar.
Subyek akan dilakukan randomisasi 1:1 dan dibagi ke dalam dua kelompok: 1. Kelompok dengan rifampisin dosis tinggi (Rifampisin oral ~35 mg/kg/hari selama 8 minggu) dikombinasikan dengan standard HZE dan 2. Kelompok dengan rifampisin dosis standar (Rifampisin oral ~10 mg/kg/hari selama 8 minggu) dikombinasikan dengan standar dosis HZE. |
|
| INA-GTM5Y9O |
Initial
|
HARVEST (Rifampisin oral dosis tinggi untuk memperbaiki luaran pada pasien dewasa dengan meningitis tuberkulosis
| Interventions: |
HARVEST merupakan uji klinik fase 3 terkontrol, multisenter, dan tersamar ganda yang bertujuan untuk menilai apakah rifampisin dosis tinggi dapat memperbaiki luaran 6 bulan dibandingkan dengan rifampisin dosis standar.
Subyek akan dilakukan randomisasi 1:1 dan dibagi ke dalam dua kelompok: 1. Kelompok dengan rifampisin dosis tinggi (Rifampisin oral ~35 mg/kg/hari selama 8 minggu) dikombinasikan dengan standard HZE dan 2. Kelompok dengan rifampisin dosis standar (Rifampisin oral ~10 mg/kg/hari selama 8 minggu) dikombinasikan dengan standar dosis HZE. |
|
| INA-AFXDQE9 |
Initial
|
Efikasi dan Keamanan Remdesivir pada Pasien COVID-19 Derajat Sedang-Berat di RSUP DR. M. Djamil Padang
| Interventions: |
Remdesivir selama 5 hari dosis Hari 1 200 mg dlm 500 cc Nacl 0,9%, hari 2-5 100 mg dlm 500 cc Nacl 0,9% VS kontrol (pengobatan tanpa anti virus) |
|
| INA-HRAMP37 |
Initial
|
Studi Efikasi dan Keamanan Terapi IVIG pada Pasien Covid19 Derajat Berat di RSPI Prof. Dr. Sulianti Saroso
| Interventions: |
Standard of Care, Standard of Care + IVIG |
|
| INA-GAXP9QZ |
Initial
|
THE USE OF SYSTEMIC CORTICOSTEROIDS IN MODERATE TO CRITICAL ILL PATIENTS WITH COVID-19
| Interventions: |
Kelompok intervensi akan menerima perawatan standar dan terapi Dexamethason dengan dosis hari 1-2 3X4 mg, hari 3-4 2X4 mg, hari 5-6 1X4 mg segera setelah pengacakan.
Kelompok pembanding akan menerima perawatan standar atau perawatan biasa dengan deksametason dosis 1x6mg hingga 10 hari. |
|
| INA-QCMRCKG |
Initial
|
Intravenous Immunoglobulin (IVIG) Sebagai Terapi Pasien Covid-19: Sebuah Uji Klinis
| Interventions: |
Terdapat lima kelompok perlakuan yaitu:
1. Kelompok 1 (kontrol): Terapi Standar
2. Kelompok 2: Terapi Standar + Dosis 0.3 g /Kg anti-COVID-19 IVIG selama 3 hari
3. Kelompok 3: Terapi Standar + Dosis 0.5 g /Kg anti-COVID-19 IVIG selama 3 hari
4. Kelompok 4: Terapi Standar + Dosis 0.3 g /Kg anti-COVID-19 IVIG selama 5 hari
5. Kelompok 5: Terapi Standar + Dosis 0.5 g /Kg anti-COVID-19 IVIG selama 5 hari |
|
| INA-S4D4ZKN |
Initial
|
COVID-REMISI
| Interventions: |
Kombinasi antar remdesivir dan plasebo atau remdesivir saja, diberikan sesuai kelompok atau arm randomisasi, sebagai berikut.
Kelompok remdesivir durasi 10 hari
Hari pertama : Loading dose remdesivir
Hari ke 2-10 : Maintenance dose remdesivir
Kelompok remdesivir durasi 5 hari
Hari pertama : Loading dose remdesivir
Hari ke 2-5 : Maintenance dose remdesivir
Hari ke 6-10 : Plasebo |
|
| INA-BDGYB4X |
Recruit
|
Ivermectin Fase II-III
| Interventions: |
Fase II
• Arm 1 : SoC + Ivermectin tablet dengan dosis 200 μg/kg sesuai
dengan berat badan akan diberikan satu kali per hari, selama
5 hari.
• Arm 2 : SoC + Ivermectin tablet dengan dosis 400 μg/kg sesuai
dengan berat badan akan diberikan satu kali per hari, selama
5 hari.
Fase III
• Arm 1 : SoC + Ivermectin tablet selama 5 hari, dengan dosis
yang aman berdasarkan uji klinik fase II.
• Arm 2 : SoC + Plasebo yang identik dengan tablet Ivermectin
sesuai dengan berat badan akan diberikan satu kali per hari,
selama 5 hari. |
|
| INA-EKR2903 |
Initial
|
NA
| Interventions: |
- Semua subjek akan berpuasa selama 10 jam semalam (09.00 - 07.00) sebelum pemberian obat. Tidak ada asupan makanan khusus yang dirancang untuk penelitian ini. Asupan air akan diizinkan sesuai keinginan kecuali selama 1 jam (jam) sebelum pemberian obat studi dan 2 jam setelahnya. Setelah titik-titik ini, air hangat akan disediakan sesuai keinginan. Tidak ada makanan yang diizinkan sampai 4 jam setelah pemberian obat studi. Makanan standar akan disajikan pada 4 jam (sarapan), 6 jam (makan siang), dan 12 jam (makan malam) setelah pemberian obat studi.
- Setelah puasa semalaman, kira-kira pukul 06.00 pada hari pengambilan sampel, diambil 5 ml sampel darah pre-dose dalam waktu satu jam sebelum pemberian obat untuk setiap periode. Setelah pemberian obat, sampel darah 5 ml akan diambil pada waktu pemberian obat 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 9, 12, 16 dan 24 jam
- Subjek harus tetap dalam posisi berbaring sampai periode 4 jam setelah pemberian obat. Subjek tidak akan diizinkan untuk keluar dari fasilitas klinis kecuali atas izin dokter yang bertanggung jawab.
- Pemantauan tanda vital (body temperature, blood pressure, heart rate/pulse rate and, respiration rate): predose, 1, 2, 4, 6, 9, 12, 24 dan 32 jam setelah pemberian obat. |
|
| INA-XH6BCFP |
Initial
|
Serological screening and treatment to prevent recurrence of tertian malaria (SSAT STUDY)
| Interventions: |
Uji coba terkontrol secara acak dengan skrining serologis dan pengobatan sebagai intervensi. Anak sekolah terpilih akan dialokasikan ke dalam dua kelompok studi: (1) skrining dan pengobatan serologis (SSAT), dan (2) kelompok kontrol. |
|
| INA-CLYNAA |
Initial
|
Seroprevalence of Hepatitis A in Indonesia part of "Seroprevalence of Hepatitis A in 3 South East Asian Countries: Indonesia, The Philippines And Vietnam"
| Interventions: |
This is study without intervention |
|
| INA-R8NGMEW |
Initial
|
The Effect of Incremental Continous Ambulatory Peritoneal Dialysis on the Preservation of Residual Kidney Function and Clinical Outcomes: A Randomized Controlled Trial
| Interventions: |
CAPD patients will be screened according to the examination results of baseline eGFR and 24-hour urine volume. Patients with significant Residual Kidney Function will be assigned as potential subject in this study and screened based on the inclusion and exclusion criteria. The significant Residual Kidney Function is defined as if a patient has minimum urine volume of 400 ml/day and residual eGFR minimum of:
- 6 mL/min/1.73 m2 for body weight 40-55 kg
- 8 mL/min/1.73 m2 for body weight 55.1-73 kg
- 9 mL/min/1.73 m2 for body weight 73.1-91 kg
- 10 mL/min/1.73 m2 for body weight 91.1-109 kg
Subjects who agree to join this study will undergo physical examination and laboratory tests (hemoglobin, ureum, creatinine, calcium, phosphate, albumin, serum iron, TIBC, ferritin, CRP, electrolyte, and peritoneal equilibration test) as baseline data; assigned as data at day-0. In addition, they will fill out the KDQOL-SFTM 1.3 questionnaire for baseline QoL data. They will be randomly assigned to intervention or control group in a 1:1 ratio using block randomization. Subjects in intervention group (Group A) will receive 1 cycle of Icodextrin with 8-12 hours dwell time at night and 2 cycles of Dianeal with dwell time 4-6 hours per day. Subjects in control group (Group B) will be receive 4 cycles of Dianeal per day with dwell time 4-6 hours each. Concentration of the glucose prescribed will be decided by the clinician based on volume status, urine production, and daily ultrafiltration. Subjects will be assessed in three months trial. The assessment for primary and secondary outcomes will be held at day-30, 60, and 90. |
|
| INA-WXPBFS9 |
Initial
|
NA
| Interventions: |
1. Kurang lebih 1 jam sebelum pemberian obat, subjek harus mandi sebelum menjalani pemeriksaan fisik untuk data tanda vital awal (suhu tubuh, tekanan darah, detak jantung / nadi, dan laju respirasi). Subjek wanita usia subur harus menjalani tes kehamilan. Data tersebut akan dicatat di CRF.
2. Keesokan paginya, sebelum obat diberikan ke subjek, botol harus dibuka. Untuk Obat Uji: tambahkan volume total 19 mL air yang dibagi menjadi 2 bagian. Untuk Obat Referensi: tambahkan volume total 20 mL air dibagi menjadi 2 bagian. Kemudian obatnya harus dikocok dengan baik setidaknya selama 30 detik pada setiap penambahan air.
3. Obat harus dikocok dengan baik sampai homogen sebelum diberikan kepada subyek. Sesuai jadwal, pengambilan sampel mulai pukul 07.00 pagi hari, subjek akan diberikan dosis tunggal 5 ml Cefixime Sirup Kering untuk kedua formulasi (obat uji dan pembanding) dengan ujung kateter jarum suntik dalam posisi duduk. Setiap subjek akan diberikan air sebanyak 240 ml. Kemudian ujung kateter jarum suntik harus dibilas minimal 3 kali dengan air. Subjek diminta diminta untuk menelan semua air yang tersisa. Kemudian subjek diminta untuk dalam posisi tegak (berdiri atau duduk) selama 1 jam setelah pemberian dosis. |
|
| INA-K7QXEST |
Complete
|
The effect of Consumption Lactococcus lactis Subsp. Cremoris Probiotics on Gut Microbiota, Food Intake and Defaecation in Indonesian Women with Constipation
| Interventions: |
The dietary supplements used in this study were hard capsules containing Lc. cremoris FC (1 X 107 cfu; 2 X 107 cfu) and a placebo. Each daily dose comprised two capsules, with hot/cold water per a day within 30 minutes after dinner during intake. |
|
| INA-HOZ2FWH |
Initial
|
Randomised Evaluation of Covid-19 Therapy (RECOVERY)
| Interventions: |
RECOVERY merupakan uji coba label terbuka dan acak pada pasien yang dirawat di rumah sakit karena COVID-19. Desain faktorial digunakan sehingga subyek yang memenuhi syarat dan setuju ikut serta dalam penelitian dapat diacak/dirandomisasi ke salah satu kelompok randomisasi utama, yaitu: (Pengacakan Utama bagian A pada protokol)
• Perawatan rutin tanpa tambahan pengobatan
• Kolkisin 500 mg (oral atau nasogastric tube) atau intravena 1x/hari selama 10 hari
atau kelompok Pengacakan Utama bagian C:
• Perawatan rutin tanpa tambahan pengobatan
• Aspirin 150 mg (oral atau nasogastric tube) atau per rektal 1x/hari hingga pasien keluar rumah sakit.
Jika kondisi subyek semakin berat dan memenuhi syarat, maka dilakukan pengacakan kedua atau lanjuta antara kelompok pengobatan berikut:
• Tidak ada pengobatan/terapi tambahan
• Tocilizumab, melalui pemberian infus intravena dengan dosis ditentukan berdasarkan berat badan sebagai berikut:
- 40 dan ≤65 kg = 400 mg
- 65 dan ≤90 kg = 600 mg
- > 90 kg = 800 mg
Catatan: berat badan dapat diperkirakan jika menimbang pasien tidak praktis
Tocilizumab harus diberikan sebagai infus intravena tunggal selama 60 menit dalam 100ml natrium klorida 0,9%. Dosis kedua dapat diberikan ≥12 dan |
|
| INA-NEB8Z5Y |
Recruit
|
Novel Coronavirus Vaccine (CHO cell) Phase III clinical trial
| Interventions: |
Investigational Vaccine: ZF2001
Name : Recombinant Novel Coronavirus Vaccine (CHO cell)
Manufacturer : Anhui Zhifei Longcom Biopharmaceutical Co., Ltd
Specifications : 0.5ml/vial. It contains 25 μg NCP-RBD protein
Ingredients : NCP-RBD, Aluminum Hydroxide Adjuvant
Dosage form : injection
The injection way: intramuscular injection of deltoid muscle of upper arm
Vaccination dose: 0.5ml
Vaccination schedule: 0,1,2 months
Placebo:
Name : Novel Coronavirus Vaccine (CHO cell) placebo (with aluminum)
Manufacturer : Anhui Zhifei Longcom Biopharmaceutical Co., Ltd
Specifications : 0.5 ml/vial. It contains 0.25mg aluminum hydroxide adjuvant
Ingredients : Aluminum hydroxide adjuvant
Dosage form : injection
The injection way: intramuscular injection of deltoid muscle of upper arm
Vaccination dose: 0.5ml
Vaccination schedule: 0,1,2 months |
|
| INA-NT3BFHA |
Recruit
|
Uji klinik (2R2): Dosis Tinggi Rifampisin versus Dosis Standar Rifampisin untuk Pengobatan Infeksi Laten TB (ILTB)
| Interventions: |
Berdasarkan panduan WHO yang telah menerbitkan rekomendasi terbaru untuk pengobatan ILTB dengan regimen Rifampisin selama 4 bulan (4R). Pada uji klinik ini kami berencana untuk memverifikasi bahwa monoterapi Rifampisin dosis lebih tinggi (20 mg/kg dan 30 mg/kg) memiliki kemanjuran yang sama dengan 4R, tanpa ada peningkatan efek samping serta aman; karena pengobatan ILTB menyiratkan pengobatan terhadap orang sehat. Uji klinik ini merupakan fase 2b, dan apabila dari uji klinik ini didapatkan bukti (evidence) baru, maka selanjutnya akan diteruskan ke uji klinik fase 3 yang melibatkan lebih banyak negara dengan jumlah subjek yang lebih banyak.
Untuk itu Intervensi yang dilakukan terhadap subyek pada uji klinik ini yaitu memberikan obat regimen Rifampisin dengan dosis harian tinggi yakni 20 mg/kg dan 30 mg/kg. Yang memiliki tujuan serta manfaat seperti berikut:
Tujuan utama:
Penyelesaian pengobatan: Membandingkan penyelesaian pengobatan tiga regimen rifampisin oral harian dengan dosis berbeda: (1) dosis standar = 10 mg/kg/hari selama 4 bulan (4R10), atau (2) dosis tinggi 20mg/kg/hari selama 2 bulan (2R20), atau, (3) dosis tinggi 30 mg/kg/hari selama 2 bulan (2R30). Penyelesaian akan didefinisikan sebagai menyelesaikan pengobatan setidaknya 90% dari dosis dalam 120% dari waktu yang diizinkan (54 dosis dalam 72 hari untuk regimen dosis tinggi 2 bulan dan 108 dosis dalam 144 hari untuk regimen standar).
Keamanan: Membandingkan efek samping tingkat 3-5 dari tiga regimen yang mengakibatkan penghentian obat studi secara permanen dan dianggap mungkin atau mungkin terkait dengan obat yang diteliti (penilaian apakah efek samping tersebut dilakukan oleh tim independen yang beranggotakan 3 orang yang tidak mengetahui ketiga regimen tersebut)).
Tujuan sekunder:
Membandingkan efek samping tingkat 1-2 dari tiga regimen yang mengakibatkan penghentian obat studi secara permanen dan dianggap mungkin atau mungkin terkait dengan obat yang diteliti oleh tim independen yang tidak mengetahui ketiga regimen tersebut (keamanan).
Membandingkan tiga regimen dalam hal kejadian TB aktif dalam 26 bulan setelah pengacakan (kemanjuran).
Manfaat Penelitian:
Beberapa manfaat yang dapat diperoleh dari penelitian ini, antara lain:
Bila terbukti penyelesaian pengobatan lebih baik dan keamanan dari regimen dosis tinggi sama baiknya dengan dosis tinggi, maka pengobatan ILTB dapat menjadi lebih singkat, hanya 2 bulan.
Subjek yang diikutsertakan dalam penelitian mendapatkan pemeriksaan skrining ILTB, pemantauan dan pemeriksaan berkala selama 26 bulan sejak dirandomisasi.
Subjek yang diikutsertakan dalam penelitian mendapatkan pengobatan ILTB yang bebas biaya. |
|
| IINA-HWO0848 |
Initial
|
Persistence and Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines in Indonesian Adults, Adolescent, Children, and Infants
| Interventions: |
Blood sampling at 3, 4 and 5 years after vaccination with one dose of Vi-DT in adults, adolescents, children and infants groups in subject Phase II clinical trial.
One dose Vi-DT vaccine in subject aged 6-23 months when receiving the primary dose. |
|
| IINA-LWE89BE |
Initial
|
Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia
| Interventions: |
This is Observational study without intervention |
|
| INA-78S909M |
Complete
|
The effects of a probiotic milk drink, Yakult®, containing Lactobacillus casei Shirota on the intestinal microbiota and intestinal environment in residents and staff at elderly houses in Indonesia
| Interventions: |
Intervention Group :
Yakult®: Fermented milk drink containing over 6.5×109 CFUs of L. casei Shirota/65 ml, 1 bottle/day for 24 weeks (168 days).
Placebo Group :
Placebo: Taste, appearance, component, and number of calories are the same as Yakult®, non-fermented milk product. 1 bottle/day for 24 weeks (168 days). |
|
| INA-XSPZF53 |
Recruit
|
Adaptive Phase I Clinical Trial of Preventive Vaccine Consisting of Autologous Dendritic Cells Previously Incubated With S-protein From SARS-CoV-2, in Subjects Negative for COVID-19 Infection and Anti-SARS-CoV-2 Antibodies
| Interventions: |
This is an adaptive Phase I trial of a vaccine consisting of autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein, with or without GM-CSF, to prevent COVID-19 in adults. |
|
| INA-TZ0XXFY |
Initial
|
The Benefits of Astaxanthin as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient
| Interventions: |
This is a randomized clinical trial, active comparator, open label, controlled study. Eligible subjects were randomly allocated to receive any of the following regiments: standard therapy consists of pregabalin, gabapentine, or amitriptyline (control group) or standard therapy and astaxanthin 6 mg tablet once daily (experimental group) |
|
| INA-LYY8GNT |
Initial
|
The Benefits of Vitamin B Combination as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient
| Interventions: |
This is a randomized clinical trial, active comparator, open label, controlled study. Eligible subjects were randomly allocated to receive any of the following regiments: standard therapy consists of pregabalin, gabapentine, or amitriptyline (control group) or standard therapy and vitamin B combination (vitamin B1 100 mg, vitamin B6 200 mg, and vitamin B12 200 mcg) once daily (experimental group) |
|
| INA-MEODDY6 |
Initial
|
The Benefits of Vitamin D 5000 IU as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient
| Interventions: |
This is a randomized clinical trial, active comparator, open label, controlled study. Eligible subjects were randomly allocated to receive any of the following regiments: standard therapy consists of pregabalin, gabapentine, or amitriptyline (control group) or standard therapy and vitamin D 5000 IU tablet once daily (experimental group) |
|
| INA-PA2HB87 |
Complete
|
Effects of Dietary Intake and Supplementation of Indigenous Probiotic Lactobacillus plantarum Dad-13 on Body Mass Index, Faecal Short-Chain Fatty Acid, and Gut microbiota of Undernourished Children in East Lombok, Indonesia
| Interventions: |
Probiotic powder "ProbioGama" with probiotics Lactobacillus plantarum Dad-13 with viability 10^9 CFU/gram. 40 Subject divided into 2 groups :
- Probiotic Group : Consume Probiotic Powder ProbioGama 1 sachet/ Day (1 sachet = 1 gram)
- Plasebo group : consume skim milk powder 1 sachet (1 sachet = 1 gram) |
|
| INA-2A8RG4R |
Complete
|
PENGARUH KONSUMSI PROBIOTIK POWDER INDIGENOUS DALAM MENYEHATKAN SALURAN PENCERNAAN PADA PENDERITA OBESITAS
| Interventions: |
Intervensi Produk Probiotik Powder dengan viabilitas 10^9 CFU/Gram/Hari pada kelompok probiotik |
|
| INA-N9A8PM2 |
Initial
|
Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC)
| Interventions: |
• Drug: Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)
• Other: Placebo
• Drug: Remdesivir |
|
| INA-K2SGZ24 |
Initial
|
NA
| Interventions: |
1. Sekitar 1 jam sebelum pemberian obat, subjek menjalani pemeriksaan fisik untuk
data tanda vital awal (suhu tubuh, tekanan darah, denyut jantung / nadi, dan laju pernapasan). Subjek perempuan usia subur harus menjalani tes kehamilan urin.
2. Pada pukul 07:00 pagi, dosis oral tunggal 150 mg Pregabalin diberikan pada masing-masing subjek dengan 240 mL air dalam posisi duduk.
3. Subjek harus tetap dalam posisi duduk sampai periode 1 jam setelah pemberian obat.
4. Pemantauan tanda vital (body temperature, blood pressure, heart rate/pulse rate and, respiration rate): predose, 1, 2, 3, 4, 12, 24 dan 36 jam setelah pemberian obat.
Subjek diinstruksikan untuk menginap satu malam sebelum dan selama periode pengambilan sampel setidaknya selama 24 jam setelah pemberian obat
- Subjek diinstruksikan untuk berpuasa dari 8 jam sebelum sampai dengan 4 jam setelah obat
administrasi
- Menu yang disajikan dan makanan yang diambil oleh subjek distandarisasi dan dicatat
- Air dapat dikonsumsi sesuai keinginan kecuali selama jangka waktu 1 jam sebelumnya sampai 2 jam setelah pemberian obat
- Tanda-tanda vital (tekanan darah, nadi, laju respirasi dan suhu tubuh) adalah dipantau dan dicatat sebelum pemberian obat, dan selanjutnya pada 1, 2, 3, 4, 12, 24 dan 36 jam setelah pemberian obat. Keamanan subjek dipantau selama seluruh studi di bawah pengawasan langsung oleh Pelajari Dokter di lokasi penelitian. |
|
| INA-1M7KY9N |
Initial
|
Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates, Lot to Lot Consistency and Antigen Interference with Co-Administered EPI Vaccines (Phase III)
| Interventions: |
Investigational product: Rotavirus RV3 Vaccine (Bio Farma); Control product: Placebo |
|
| INA-2GHFOKN |
Initial
|
International SARS-CoV-2 Infection Observational Study (ICOS)
| Interventions: |
Tidak ada Intervensi |
|
| INA-BB6K0Q7 |
Initial
|
Reducing the risk of Plasmodium vivax relapse after acute Plasmodium falciparum malaria in co-endemic areas - a randomized controlled trial (PRIMA STUDY)
| Interventions: |
Uji klinis terbuka, acak terkontrol dengan dua arm pada penderita P. falciparum, yaitu:
i. Kelompok intervensi dengan pengobatan tambahan untuk P. vivax
ii.Kelompok kontrol tanpa pengobatan tambahan untuk P. vivax |
|
| INA-H9QLN22 |
Recruit
|
Fase III, Acak-terbuka, Uji Klinik Efikasi dan Keamanan Favipiravir pada Pasien Covid-19 di Indonesia
| Interventions: |
Pemberian obat Uji dan Komparator
Obat Uji
Hari 1: Favipiravir 2 x 1600 mg (8 tablet),
Hari 2 sampai hari ke 7 hingga maksimal 14 hari :
Favipiravir 2 x 600 mg (3 tablet) sehari,
+ Azithromycin 1 x 500/hari selama 5 hari
Komparator :
+ Azithromycin 1 x 500/hari selama 5 hari |
|
| INA-HL5Q9B1 |
Initial
|
PlaSenTer
| Interventions: |
Plasma Convalescet @200mL, 2x pemberian dengan jangka waktu 3 hari |
|
| INA-6E2YX0X |
Recruit
|
Solidarity Trial
| Interventions: |
Local standard of care alone,
OR local standard of care plus one of
• Remdesivir (daily infusion for 10 days)
• Chloroquine or hydroxychloroquine (two oral loading doses, then orally twice daily for 10 days)
• Lopinavir with Ritonavir (orally twice daily for 14 days)
• Lopinavir with Ritonavir (ditto) plus Interferon (daily injection for 6 days). |
|
| INA-TX6YYSS |
Complete
|
Uji Klinis Fase III, Multisenter, Acak Terkontrol, Tersamar Ganda Membandingkan Efikasi Dan Keamanan Kombinasi Baru Lopinavir/Ritonavir-Azithromycin, Lopinavir/Ritonavir-Doxycycline, Serta Hydroxychloroquine-Azithromycin Dengan Obat Standar Pada Pasien COVID-19 Yang Dirawat Di Rumah Sakit Dengan Derajat Ringan, Sedang, Dan Berat Yang Tidak Menggunakan Ventilator
| Interventions: |
Pasien positif COVID-19 yang dibuktikan dengan hasil PCR dan memenuhi kriteria inklusi serta eksklusi pada penelitian ini diberikan obat uji klinik selama 7-14 hari. Selama penelitian dilakukan evaluasi: 1. Evaluasi laboratorium (pemeriksaan darah lengkap, fungsi liver, fungsi ginjal, CRP, D-dimer, elektrolit) pada H-1 dan H-7. 2. Pemeriksaan EKG setiap hari 3. Pemeriksaan Rontgen Dada H-1, H-7, dan H-14, 4. Pemeriksaan PCR Kualitatif dan Kuantitatif (Jumlah Copy Virus) pada H-1, H-3, dan H-7. 5. Pemeriksaan Sitokin pada H-1 dan H-7. |
|
| INA-QCA4OWA |
Initial
|
Therapeutic Study to Evaluate the Safety and Efficacy of DW-MSC in COVID-19 Patients: Randomized, Double-blind, and Placebo-controlled
| Interventions: |
Subjects who meet the final inclusion and exclusion criteria are randomized to the test groups (low-dose group and high-dose group) or control group (placebo group) in a ratio of 1:1:1. Subjects assigned to the test groups were administered intravenously once with 5 x 107cells of DW-MSC for the low-dose group or 1 x 108cells for the high-dose group after registration. |
|
| INA-WXFM0YX |
Initial
|
A Phase III, Observer-blind, Randomized, Placebo-controlled Study of the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18-59 Years in Indonesia
| Interventions: |
Investigational product: SARS-CoV-2 vaccine (inactivated)
Control product: placebo |
|
| INA-1LX0O6E |
Recruit
|
KAPSUL EKSTRAK ETANOL 70% TERFRAKSINASI DAUN J. gendarussa Burm. f SEBAGAI OBAT KB PRIA
| Interventions: |
Subyek akan diminta untuk minum dua kapsul ekstrak dengan dosis 450 mg ekstrak etanol 70% terfraksinasi daun J. gendarussa atau plasebo satu kali sehari, selama 12 bulan.
Pada masa subur istri, pasangan diminta untuk melakukan hubungan seksual. Pasangan akan diamati selama 12 bulan masa masa minum obat, yang dilanjutkan dengan pengamatan reversibilitas 72 hari setelah putus obat, sesuai dengan lamanya proses spermatogenesis. |
|
| INA-QXZNETK |
Initial
|
Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled prophylaxis study (COPCOV)
| Interventions: |
The study is a double-blind, randomised, placebo-controlled trial that will be conducted in healthcare settings. After obtaining fully informed consent, we will recruit healthcare workers, or other individuals at significant risk, who can be followed up reliably for up to 5 months. In Asia they will be randomised to receive either chloroquine or placebo (1:1 randomisation). In Europe they will be randomised to receive either hydroxychloroquine or placebo (1:1 randomisation).
A loading dose of 10 mg base/kg (four 155mg tablets for a 60kg subject), followed by 155 mg daily (250mg chloroquine phosphate salt or 200mg of or hydroxychloroquine sulphate) will be taken for 3 months. Subsequent episodes of symptomatic respiratory illness, including symptomatic COVID-19, clinical outcomes, and asymptomatic infection with the virus causing COVID-19 will be recorded during the follow-up period. If they are diagnosed with COVID-19 during the period of prophylaxis, they will continue their prophylaxis unless advised to do so by their healthcare professional until they run out of their current supply of chloroquine/placebo at home. They will not collect more. They will be followed up for 28 days (up until a maximum of 60 days if not recovered at 28 days). |
|
| INA-EW74C1N |
Recruit
|
The Use of Biomaterials as Bone Substitute for Alveolar Cleft Patients
| Interventions: |
Intervention divided into 3 group;
Group 1 : Alveolar cleft repair (gnatoplasty) with Poly-P as bone substitute,
Group 2 : Alveolar cleft repair (gnatoplasty) with bone ceramic + Poly-P as bone substitute,
Group 3 : Alveolar cleft repair (gnatoplasty) with bone ceramic + Microfragmented fat (MFAT) as bone substitute. |
|
| INA-KGMRF0T |
Initial
|
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B at Birth dose (using different source of Hepatitis B), in Indonesian Infants
| Interventions: |
Investigational product: DTP-HB-Hib Vaccine (Bio Farma) using different source of Hepatitis B bulk and Recombinant Hepatitis B (Bio Farma) using different source bulk
Control Product: Pentabio Vaccine® (Bio Farma) and Recombinant Hepatitis B® vaccine (Bio Farma) |
|
| INA-HETTL12 |
Recruit
|
D2EFT
| Interventions: |
Yes: Dolutegravir, Darunavir, Ritonavir |
|
| INA-OL70Y5G |
Complete
|
Integrasi Kesehatan Jiwa di Klinik HIV untuk Meningkatkan Keberhasilan Pengobatan Antiretroviral: Skrining Gangguan Depresi pada Orang Dengan HIV di Rumah Sakit
| Interventions: |
Tidak ada intervensi |
|
| INA-WHMG3FX |
Initial
|
The Benefit of Add on Vitamin D or Vitamin B combination or Either for Painful Diabetic Neuropathy
| Interventions: |
Add on vitamin D (400 IU) per day to standard treatment (pregabalin, gabapentin, or amitryptilin) |
|
| INA-MZXONZG |
Initial
|
Immunogenicity and Safety of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults, Children and Infants, Lot to lot consistency, Non-inferiority to PQed TCV and Typhoid Vi Polysaccharide Vaccine
| Interventions: |
Vaksin Tifoid Konjugat (Vi-DT) |
|
| INA-53EA9LH |
Initial
|
The role of DLBS1033 in the management of acute ischemic stroke patients: study protocol for a randomized controlled study
| Interventions: |
This is a randomized controlled open label trial. There will be 2 groups in this study, group 1 consists of subjects treated with DLBS1033 + standard therapy of ischemic stroke, whereas group 2 consists of subjects treated with placebo of DLBS1033 + standard therapy of ischemic stroke. DLBS1033 and placebo of DLBS1033 will be given 2 tablets three times per day for 30 days. |
|
| INA-F3KQ3DK |
Initial
|
Comparison of Intravenous Ibuprofen and Ketorolac for Acute Musculoskeletal Pain from Various Etiologies
| Interventions: |
This is a quasi experimental, non randomized, non equivalent, active comparator, open label study. The intervention in this study is an intravenous 800 mg ibuprofen. The intravenous ibuprofen will be given every 12 hours. We will need 4 intravenous ibuprofen injection for every patient. There will be a total need of 120 IV ibuprofen injection for this study. The control in this study is an intravenous 30 mg ketorolac. The ketorolac injection will be given every 12 hours. |
|
| INA-FBT1T7P |
Initial
|
Evaluasi Ekonomi Intervensi Koroner Perkutan pada Pasien Angina Pektoris Stabil dan Sindrom Koroner Akut di Indonesia
| Interventions: |
Penelitian ini tidak melakukan intervensi kepada subjek. |
|
| INA-DPS3T9B |
Initial
|
Safety and Preliminary of Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children
| Interventions: |
Investigational Product Recombinant Hepatitis B (Bio Farma) Vaccine
Form Liquid (in uniject)
Dose 1 mL
Route Intramuscular injection (deltoid)
Batch Number 3660318UK
Expiry Date September 2020
Active Comparator Recombinant Hepatitis B (Bio Farma) Vaccine®
Form Liquid (in uniject)
Dose 1 mL
Route Intramuscular injection (deltoid)
Batch Number 3660718
Expiry Date 31 August 2020 |
|
| INA-OB1RAKC |
Initial
|
A Comparison Between Non-steroid Anti-inflammatory Drugs and Its Combination with Eperisone hydrochloride in Acute Non-Spesific Back Pain
| Interventions: |
There are 2 groups of subjects. First group will receive a combination of eperisone hydrochloride and ibuprofen, whereas second group will only receive ibuprofen. We use 50 mg of eperisone hydrochloride taken three times per day and 400 mg of ibuprofen taken two times per day. Each medication must be taken every day for 4 weeks. Each subject will also receive 500 mg of paracetamol as a rescue medication. |
|
| INA-0BD1YLW |
Initial
|
Immunogenicity & Safety of Bio Farma’s Measles-Rubella (MR) Vaccine in Indonesian Infants
| Interventions: |
IP: Vaksin Measle - Rubella (MR) Biofarma
Active Comparator: Vaksin Measle Rubella (MR) SII |
|
| INA-55NX6PA |
Initial
|
Protectivity and Safety Following Recombinant Hepatitis B Vaccine
| Interventions: |
3 doses of Recombinant Hepatitis B |
|
| INA-ZN6M5MG |
Initial
|
Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria
| Interventions: |
Sanaria® PfSPZ Vaccine: Radiation attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ) administered by direct venous inoculation (DVI).
Normal Saline (0.9% NaCl): The placebo control administered by DVI.
Sanaria® PfSPZ-CVac: Infectious, aseptic, purified, cryopreserved PfSPZ (Sanaria® PfSPZ Challenge) administered by DVI to individuals taking chloroquine (CQ) chemoprophylaxis.
Normal Saline (0.9% NaCl): The placebo control administered by DVI to individuals taking CQ chemoprophylaxis.
Diluent. The diluent for PfSPZ Vaccine and PfSPZ Challenge will be phosphate buffered saline (PBS) with 1% human serum albumin. |
|
| INA-0BBB401 |
Initial
|
INA105 - SchisCCA
|
| INA-DTPL801 |
Initial
|
START Study
| Interventions: |
Investigational product:
- Product: Deferiprone oral solution 80 mg/mL
- Dose: 25, 50, or 75 mg/kg/day, divided t.i.d.
- Mode of administration: Oral
Reference product:
- Product: Placebo
- Dose: Volume of solution matching that required for a 25, 50, or 75 mg/kg/day dose of active product, divided t.i.d.
- Mode of administration: Oral |
|
| INA-Z7X0Q5P |
Recruit
|
Pengaruh penambahan kurkumin pada pasien mieloma multipel
| Interventions: |
Kurkumin 8 gram/hari selama 4 bulan |
|
| INA-N910C51 |
Complete
|
Comparative Study of Efficacy and Safety Lynestrenol versus Exluton® in Women of Childbearing Age
| Interventions: |
This is a prospective, randomized, open label, comparative, parallel study to evaluate efficacy and safety of 0.5 mg lynestrenol during 12 months of drug administration.
The randomization code is tabulated for all subjects according to block randomization with a block size of 4 (Dixon & Massey, 1969, p 447).
The study will be conducted in PT Equilab International as the study center in collaboration with some midwife clinics in Jakarta and surrounding areas.
The data of pregnancy occurrence will be evaluated by urine HCG test every 2 months at until 12 months of evaluation period.
The data of adverse events occurred during the study will be collected based on subject’s diary, anamnesis, and medical examination.
Subjects are not allowed to use other contraception except the investigational product (0.5 mg Lynestrenol that dispensed from the study site) |
|
| INA-8EAHA56 |
Complete
|
Studi Efektivitas Monoplant® dibandingkan dengan Indoplant®
| Interventions: |
Studi ini merupakan uji klinik fase III, ‘terbuka’ (‘open label’ Randomized Clinical Trial), dilakukan randomisasi serta multisenter, dengan membandingkan dua macam susuk KB yaitu Monoplant® dan Indoplant® yang dilakukan pada wanita sehat Indonesia. Blok random alokasi persepuluhan dan ditetapkan secara random dibagi 5 Monoplant dan 5 Indoplant. Total sampel yang akan diamati dalam studi ini: 450 subjek wanita pemakai Monoplant® dan 450 subjek wanita pemakai Indoplant® di 5 (lima) senter di Indonesia, yaitu Jakarta, Semarang, Surabaya, Palembang dan Makassar. Tiap senter akan merekrut lebih kurang 180 subjek (90 akseptor Monoplant dan 90 akseptor Indoplant), untuk kedua jenis susuk KB ini tergantung dari kemampuan dan kesanggupan senter merekrut sampelnya.
Pengamatan terhadap subjek dilakukan selama 3 tahun. Pengambilan darah untuk pemeriksaan kadar LNG dilakukan subsampel (33 subjek) untuk masing-masing susuk KB Monoplant dan Indoplant, khususnya pada subjek di senter Jakarta. Pemeriksaan kadar LNG dalam darah dilakukan di PT. Equilab Internasional. |
|
| INA-P1WG34P |
Recruit
|
INA-PROACTIVE
| Interventions: |
No Intervention |
|
| INA-LML8DP8 |
Complete
|
Profil Keamanan Vaksin Td (Bio Farma) pada Ibu Hamil di Indonesia
|
| INA-2FRR4L5 |
Initial
|
Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children and Neonates (Phase I)
| Interventions: |
Adult&Children: One dose of Rotavirus Vaccine
Neonates: Three doses of Rotavirus Vaccine |
|
| INA-BCER292 |
Complete
|
Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children
| Interventions: |
1 dose Measles Rubella (MR) vaccine |
|
| INA-3PTS6EX |
Complete
|
Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population
| Interventions: |
9-40 years old: 1 dose of Quadrivalent Influenza Vaccine
6 months - 8 years old: 2 dose of Quadrivalent Influenza Vaccine |
|
| INA-35ST1PS |
Initial
|
Safety and immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Indonesian adults, adolescents, children and infants (Phase II)
| Interventions: |
1 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine |
|
| INA-AB1DBOS |
Complete
|
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)
| Interventions: |
2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine |
|
| INA-C273S0L |
Complete
|
Immunogenicity and Safety Profile of Primary Dose of bivalent OPV (bOPV Bio Farma) Given Simultaneously with Pentabio® and Inactivated poliovirus vaccine (IPV) at the 4th Visit in Indonesian Infants
| Interventions: |
bOPV one dose corresponds to 2 drops (0.1ml). The vaccine shall be given orally.
The subject received bOPV, Pentabio and IPV according to the study schedule. |
|
| INA-H9W8EPN |
Recruit
|
TT063 STUDY
| Interventions: |
The following 2 groups are examined. The subjects are randomly allocated to these groups at the ratio of 1:1.
SFPP group: One patch of SFPP is applied to the assessed knee once daily.
Diclofenac (DC) group: Two gram of diclofenac gel per application is applied to the assessed knee 4 times daily.
Pre-treatment Drugs: Patients take celecoxib 200 mg per day prescribed by investigator from screening visit (1st visit) to washout visit (2nd visit) as the pre-treatment for knee OA.
Rescue Drugs: Use of paracetamol 1,000 mg once daily as the rescue drugs for knee pain is permitted from washout visit (2nd visit) to the end of final tests and observation only when the subjects cannot tolerate their knee pain (ex. they cannot rise up from chair).
[Exception]
Rescue drugs cannot be used within two days before the scheduled site visits. |
|
| INA-7GNRTO6 |
Recruit
|
Tuberculosis Research of INA-RESPOND On Drug Resistance
| Interventions: |
Tidak ada Intervensi; Observational |
|
| INA-PLE3XOP |
Recruit
|
Implementing a Combination of Clinical Parameters (Rapid Diagnostic Tests (RDTs), Biomarkers, and Standard of Care Procedures (SoCs) for the Etiology Diagnoses of Pneumonia in Pediatric Patients to Improve Clinical Management in Indonesia.
| Interventions: |
Not Applicable, this is observational study |
|
| INA-ODE8ELW |
Complete
|
S-Collate
| Interventions: |
All clinical information and laboratory parameters documented for this observational study prior to start of
PEG IFN treatment and during this study were routinely assessed as SOC and not for the purpose of this
study. Patient’s medical history, demographics, and disease characteristics were extracted from the medical
record, as well as the CHB treatment observations (dose and exposure), concomitant medication and AEs.
To evaluate serological and virological treatment response the respective tests were done as routine
procedures, test kits and frequency of measuring depending on SOC in the respective clinic/practice.
Patients were observed for the duration of PEG IFN treatment and for up to 3 years afterwards. |
|
| INA-XL122KL |
Complete
|
FastAct II
| Interventions: |
In this phase 3 trial, patients with untreated stage IIIB/IV non-small-cell lung cancer were randomly assigned in a 1:1 ratio by use of an interactive internet response system with minimisation algorithm (stratified by disease stage, tumour histology, smoking status, and chemotherapy regimen) to receive six cycles of gemcitabine (1250 mg/m(2) on days 1 and 8, intravenously) plus platinum (carboplatin 5 × area under the curve or cisplatin 75 mg/m(2) on day 1, intravenously) with intercalated erlotinib (150 mg/day on days 15-28, orally; chemotherapy plus erlotinib) or placebo orally (chemotherapy plus placebo) every 4 weeks. With the exception of an independent group responsible for monitoring data and safety monitoring board, everyone outside the interactive internet response system company was masked to treatment allocation. Patients continued to receive erlotinib or placebo until progression or unacceptable toxicity or death, and all patients in the placebo group were offered second-line erlotinib at the time of progression. The primary endpoint was PFS in the intention-to-treat population. |
|
| INA-4Q9Y8KM |
Complete
|
ActUp
| Interventions: |
This is a 6-month non-interventional, observational, post-marketing, multi-center and local study in RA patients, who are currently being treated with tocilizumab.
This study is observational therefore no additional visits will be required, no study-specific medication will be administered and no other interventional procedures additional to those comprising routine clinical practice will be performed.
The co-morbidities of patients meeting all selection criteria will be reviewed and patients will be followed-up over a 6-month observation period.
Since patients have initiated treatment prior to study start-up, data collection is partially retrospective.
Data collection will include the following sources:
- Patients’ co-morbidities.
- Data recorded by the principal investigator and collaborators during the routine visits of the patient. Since the study is observational, the visits are those pre-scheduled as part of usual clinical practice. These include:
- One enrolment visit (this visit may occur up to 8 weeks after the first tocilizumab treatment, and in this case data collection will be retrospectively collected up to the first tocilizumab treatment).
- Usual follow-up visits according to the center’s practice, which will take place during the study observation period up to 6 months after tocilizumab treatment initiation.
- One final visit, corresponding to that performed nearest to 6 months after tocilizumab treatment initiation.
Additional tests for the recruited patients are not foreseen, since this is an observational study. The doses and duration of treatment will be stipulated by the Investigator, according to local guidelines and/or routine clinical practice.
No study-specific drug will be administered. The dose and duration of treatment before, during, and after the study will be based upon the Investigator’s judgment and in accordance with the label and local regulations.
Tocilizumab administration may occur as per routine practice and following the local label. Treatment-related information (including efficacy and safety information, where available) may be collected at the same time-points as tocilizimab administration, but will be at the discretion of the investigator in line with local routine practice.
The study population will include patients with moderate to severe RA, according to ACR criteria [13] and DAS28 joint scores [43], in whom the treating physician has made the decision to commence tocilizumab treatment (in accordance with the local label). This can include patients who have received tocilizumab treatment within 8 weeks prior to the enrollment visit. Furthermore, patients must have given their informed consent and must not meet any of the exclusion criteria |
|
| INA-P0Q2OY0 |
Recruit
|
SafeHer
| Interventions: |
Eligible patients with HER2-positive EBC will be allocated to one of the two following cohorts at the investigator’s discretion:
• Cohort A (approximately 1800 patients): trastuzumab SC 600 mg via assisted
administration into the thigh over a period of approximately 5 minutes using
handheld syringes with hypodermic needles
• Cohort B (approximately 700 patients): trastuzumab SC 600 mg, first assisted,
then self-administered into the thigh over a period of approximately 5 minutes using
the SID. For enrollment into Cohort B, patients need to be willing to self-administer
the study drug from the SID based on personal instructions/training provided by an
HCP during the first assisted administration in addition to a quick reference guide
and an instructional animation describing the injection device handling and use,
including how to respond if the SID loses sufficient contact with the body. |
|
| INA-NK1QGRZ |
Complete
|
A RANDOMIZED, OPEN-LABEL, MULTI-CENTRE STUDY TO EVALUATE PATIENT PREFERENCE WITH SUBCUTANEOUS ADMINISTRATION OF RITUXIMAB VERSUS INTRAVENOUS RITUXIMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CD20+ DIFFUSE LARGE B-CELL LYMPHOMA OR CD20+ FOLLICULAR NON-HODGKIN’S LYMPHOMA GRADES 1, 2 OR 3A
| Interventions: |
This will be an open-label, randomized study and therefore treatment allocation will not be concealed.
Eligible patients will be randomly allocated to Treatment Arm A (rituximab SC → rituximab IV) or Arm B (rituximab IV → rituximab SC) with a 1:1 ratio before dosing on Day 1 of Cycle 1.
Randomization will occur using a centralized IxRS. Patients will be stratified according to age ( |
|
| INA-A7OB6TW |
Initial
|
Applying Wolbachia to Eliminate Dengue (AWED) Trial
| Interventions: |
Intervention arm: Deployment of Wolbachia-infected Aedes aegypty mosquitoes, in addition to standard practice dengue control activities
Comparison arm: No intervention, Standard practice dengue control activities |
|
| INA-GC3B3QY |
Complete
|
NA
| Interventions: |
Tahap pertama: dilakukan pengambilan data ibu HIV dan bayinya. Tahap kedua: dilakukan pemeriksaan anti HIV sebelum dan saat persalinan dan bila anti HIV positiff, dilanjutkan pemeriksaan jumlah CD4 ibu. Pada saat bayi yang baru lahir dari ibu dengan HIV positif berusia 48 jam diperiksa PCR-DNA untuk menentukan satus infeksi bayi dan status terjadinya transmisi intra uterin. Juga dicatat apakah ibu sudah mendapat terapi ARV sebelum dan saat hamil. Semua bayi yang lahir dengan status HIV ibu positif tidak diberikan ASI. Bayi kemudian mendapatkan profilaksis ARV berupa zidovudin (dan nevirapin bila ibu belum mendapat ARV selama hamil) sesuai rekomendasi WHO selama 6 minggu. Setelah 6 minggu pemberian profilaksis ARV, bayi diperiksa PCR RNA. Semuabayi dengan hasil PCR-DNA dan atau PCR-RNA positif, langsung diberikan terapi ARV. Konfirmasi ulang dilakukan pemeriksaan PCR RNA pada usia bayi 12 minggu untuk menentukan status akhir infeksi pada bayi. |
|
| INA-4E24W1E |
Complete
|
NA
| Interventions: |
Pasien dibagi dalam 2 kelompok A dan B (setelah randomisasi) masing-masing mendapatkan obat sesuai pengelompokaan subyek selama 10 hari. Vitamin E menggunakan Santa E chewable caplet suatu DL-alpha-tocopheol dengan dosis 40 UI/hari (setara dengan Santa E 40mg) satu kali sehari yang dibuat dalam bentuk puyer. Placebo menggunakan sakarin dengan dosis dan dibuat salam bentuk puyer yang serupa dengan Santa E. |
|
| INA-F7X6NA4 |
Initial
|
NA
| Interventions: |
Injeksi stem cells |
|
| INA-SSS4TD0 |
Complete
|
Mesenchymal Stem cells ,spinal cord injury
| Interventions: |
Penyuntikan steam cells |
|
| INA-OO80ADB |
Initial
|
Global Safety T-DM1 Trial
| Interventions: |
- Test product: Trastuzumab emtansine (T-DM1)
- Target population:
This study will enroll patients with human epidermal growth factor receptor 2 (HER2)positive, unresectable, locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have previously received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy.
- Study design:
Patients will be divided into two cohorts: Cohort 1 (approximately 2000 patients) and Cohort 2 (approximately 220 patients only of Asian race). Patients in each cohort will be administered trastuzumab emtansine intravenously every 3 weeks at a dose of 3.6 mg/kg until one of the following conditions, whichever occurs first: unacceptable toxicity, withdrawal of consent, disease progression, death, or up to a maximum of 2 years after the last patient has been enrolled into Cohort 1 (for patients in Cohort 1) or Cohort 2 (for patients in Cohort 2). |
|
| INA-BXNGOQD |
Initial
|
Global Safety T-DM1 Trial
| Interventions: |
- Test product: Trastuzumab emtansine (T-DM1)
- Target population:
This study will enroll patients with human epidermal growth factor receptor 2 (HER2)positive, unresectable, locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have previously received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy.
- Study design:
Patients will be divided into two cohorts: Cohort 1 (2000 patients) and Cohort 2 (220 patients only of Asian race). Patients in each cohort will receive trastuzumab emtansine until one of the following conditions, whichever occurs first: unacceptable toxicity, withdrawal of consent, disease progression, death, or up to a maximum of 2 years after the last patient has been enrolled into Cohort 1 (for patients in Cohort 1) or Cohort 2 (for patients in Cohort 2) |
|
| INA-KPA0DYA |
Complete
|
NENOIN Study
| Interventions: |
NA
NENOIN STUDY is designed to be a Phase IV/observational study and non-interventional. This observational study will not interfere with treatment prescription by Investigators. Accordingly, the Investigator will decide in advance the best therapeutic strategy for each subject according to current practice, regardless of the potential participation of the subject in the study. Subsequently, if the prescribed treatment is to be in line with the study protocol inclusion criteria, the Investigator will consider the possibility of including the subject in the study if subject signs informed consent form. |
|
| INA-7GNRTO6 |
Initial
|
INA102 – TUBERCULOSIS RESEARCH OF INA-RESPOND ON DRUG RESISTANCE (TRIPOD)
|
| INA-9WS4RE6 |
Recruit
|
INA101: The Etiology of Acute Febrile Illness Requiring Hospitalization (AFIRE)
|
| INA-RX5D5QD |
Recruit
|
Uji Klinis Probiotik Lactobacillus plantarum pada Pasien Dermatitis Atopik Anak di RSUD Dr. Soetomo Surabaya
| Interventions: |
• Metode Intervensi / Eksperimental
Metode uji klinis terkontrol acak, tersamar ganda, tanpa pemilihan pasangan serasi, desain paralel
• Bahan Uji
➢ Bahan uji pada kelompok perlakuan yaitu Lactobacillus plantarum 1,120 gram (10 pangkat 10 Colony Factor Unit)
➢ Bahan uji pada kelompok kontrol yaitu plasebo berupa campuran susu skim dan avicel (selulose)
• Kondisi Kesehatan Subyek
Pasien dermatitis atopik anak usia 0-14 tahun dengan keadaan umum baik dan memenuhi kriteria inklusi |
|
| INA-R5PG64K |
Recruit
|
Uji Klinis Gel Produk Metabolisme Sel Punca Membran Amnion pada Penyembuhan Luka Kronis Telapak Kaki Pasien Kusta
| Interventions: |
Metode Intervensi/Eksperimental : Uji klinis terkontrol, pemilihan pasangan serasi,desain paralel
Bahan Uji:
- Pada kelompok perlakuan : produk metabolit Amniotic Membrane Stem Cell (AMSC) yang diperoleh
dari Laboratorium Stem Cell, Institute Tropical Disease, Universitas Airlangga, yang dibuat
gel terlebih dahulu supaya dapat diaplikasikan pada luka.
- Pada kelompok kontrol : framycetin gauze dressing
Kondisi Kesehatan Subyek Penelitian : Pasien Morbus Hansen dengan keadaan umum baik, dengan ulkus plantar kronis sederhana yang memenuhi kriteria inklusi dan eksklusi |
|
| INA-DCD9X4Y |
Recruit
|
Indonesia Frailty, Aging, and Longitudinal Study (INA-FRAGILE)
| Interventions: |
Observational: Cohort Prospective |
|
| INA-Z758Y83 |
Recruit
|
Oral Triiodothyronine for Children Undergoing Cardiopulmonary Bypass in Indonesia
| Interventions: |
Experimental: Tetronine
Oral T3 (Tetronine) is given 1 mcg/kg every 6 hourly through naso-gastric tube since induction of anesthesia for 60 hours
Intervention: Drug: Tetronine
Placebo Comparator: Placebo
Placebo (saccharin lactic) is given every 6 hourly through naso-gastric tube since induction of anesthesia for 60 hours
Intervention: Drug: Placebo |
|
| INA-D1C540Y |
Initial
|
manfaat xilostazol untuk perbaikan luka pada gangren diabetik
| Interventions: |
minum oabt dua kali sehari.................
..................
.............. |
|
| INA-YHDPEN2 |
Initial
|
Pengaruh Rokok terhadap kanker paru
| Interventions: |
Bahan : Rokok
Placebo : Permen |
|
| INA-BK9O54S |
Initial
|
High-dose Rifampicin for the Treatment of Tuberculous Meningitis: a Dose-finding Study (ReDEFINe)
| Interventions: |
Experimental: Rifampicin 900 mg per oral
Twenty patients will receive 2 tablets of 450 mg Rifampicin and 1 tablet of placebo once daily for 30 days.
Unconscious subjects will receive oral drugs via nasogastric tubes (NGT)
After completion of one-month treatment, patients will receive 1 tablet of 450 mg Rifampicin.
Along with study drug and placebo, patients will receive other oral TB drugs (INH, Ethambutol, and Pyrazinamide) and pyridoxin, in accordance to National TB Program guidelines for 6 months.
Patients will also receive dexamethasone in decreasing dose (in 6-8 weeks, according to TBM severity grade on admission)
Placebo
Patients receiving 450 mg rifampicin will receive additional 2 placebo tablets, while those who receive 900 mg rifampicin will receive 1 placebo tablet.
Patients receiving 1350 mg rifampicin will not receive any placebo tablet.
With this arrangement, every subject will receive 3 tablets of study drugs.
Drug: Rifampicin Patients in experimental arms will receive either 1 or 2 additional tablets of rifampicin.
Placebo tablets will be added accordingly, so that every study subject will receive 3 tablets of rifampicin plus placebo as described in the Arms section.
Other Name: Rifampisin - Kimia Farma
Drug: Other TB drugs Along with study drug and placebo, patients will receive other oral TB drugs (INH, Ethambutol, and Pyrazinamide) and pyridoxin, in accordance to National TB Program guidelines for 6 months.
Unconscious subjects will receive oral drugs via nasogastric tubes (NGT)
Drug: Adjuvant dexamethasone Patients will receive dexamethasone in decreasing dose (in 6-8 weeks, according to TBM severity grade on admission) |
|