: 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.

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT Equilab International
No Registry
INA-H0MOBSZ
Tanggal Input Registry : 24-06-2022

24-03-2021
To find out whether the bioavailability of 100 mg sitagliptin film-coated tablet produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals is equivalent to that of 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)
N/A
 
: 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.
: 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.
Eksperimental
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.
24
 

Inclusion Criteria:

1. Willing to provide written informed consent to participate in the study. 2. Healthy male and female subjects with absence of significant disease or clinically significant abnormal laboratory values. 3. Aged 18 – 55 years. 4. Preferably non-smokers or smoke less than 10 cigarettes each day. 5. Body mass index within 18 to 25 kg/m2. 6. Vital signs (after 10 minute rest) must be within the following ranges: - Systolic blood pressure : 100 – 129 mmHg - Diastolic blood pressure : 60 – 84 mmHg - Pulse rate : 60 – 90 bpm

Exclusion Criteria:

1. History of allergy or hypersensitivity or contraindication to cefixime or allied drug. 2. Pregnant or lactating female 3. Any major illnesses in the past 90 days or clinically significant ongoing chronic medical illness. 4. Presence of any clinically significant abnormal values during screening 5. Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV. 6. Reactive result for COVID-19 rapid antigen test (this criteria will only be applied if the study conduct during pandemic condition). 7. Clinically significant hematology abnormalities. 8. Clinically significant electrocardiogram (ECG) abnormalities. 9. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug 10. Past history of anaphylaxis or angioedema. 11. History of drug or alcohol abuse within 12 months prior to screening for this study. 12. Participation in any clinical trial within the past 90 days 13. History of any bleeding or coagulative disorders. 14. Presence of difficulty in accessibility of veins in left or right arm. 15. A donation or significant blood loss within 90 days 16. Intake of any prescription (especially cefixime or ofloxacin), non-prescription drug, food supplements or herbal medicines within 21 days
 
No. KET-1460/UN2.F1/ETIK/PPM.00.02/2020 (Amandemen : No. S-169/UN2.F1/ETIK/PPM.00.02/2021)
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RG.01.02.321.03.21.00044/UB
BE. 643/EQL/2020
Liana Wijaya, M.Biomed ; Kartika Widyanty