Bioequivalence Study of Sitagliptin Phosphate 100 mg Film-Coated Tablets Manufactured by PT BrightGene Biomedical Indonesia in Comparison with Januvia™ 100 mg Film-Coated Tablets Manufactured by Organon Pharma (UK) Limited, Cramlington – England, Registered and Packed by PT Organon Pharma Indonesia Tbk, Pasuruan, Jawa Timur – Indonesia, Distributed by PT Merck Sharp & Dohme Indonesia, Jakarta - Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
NA
No Registry
INA-4YSRMQS
Tanggal Input Registry : 02-08-2024

04-07-2024
AUC 0-t, Cmax
AUC 0-inf, Tmax, Half life
 
Bioequivalence Study of Sitagliptin Phosphate 100 mg Film-Coated Tablets Manufactured by PT BrightGene Biomedical Indonesia in Comparison with Januvia™ 100 mg Film-Coated Tablets Manufactured by Organon Pharma (UK) Limited, Cramlington – England, Registered and Packed by PT Organon Pharma Indonesia Tbk, Pasuruan, Jawa Timur – Indonesia, Distributed by PT Merck Sharp & Dohme Indonesia, Jakarta - Indonesia
Bioequivalence Study of Sitagliptin Phosphate 100 mg Film-Coated Tablets Manufactured by PT BrightGene Biomedical Indonesia in Comparison with Januvia™ 100 mg Film-Coated Tablets Manufactured by Organon Pharma (UK) Limited, Cramlington – England, Registered and Packed by PT Organon Pharma Indonesia Tbk, Pasuruan, Jawa Timur – Indonesia, Distributed by PT Merck Sharp & Dohme Indonesia, Jakarta - Indonesia
Observational
20
 

Inclusion Criteria:

Inclusion criteria The inclusion criteria were subjects who/with: 1. Subjects had read the subject information and were able to give written informed consent for participation in the study and comply with the study protocol/procedures. 2. Subjects healthy male and female 3. Subjects’ age ranges from 18 – 55 years. 4. Subjects’ body mass index between 18 – 25 kg/m2 5. Subjects had a normal electrocardiogram. 6. Subjects had resting vital signs (after 10 – 15 minutes of resting) were within the following ranges - Systolic blood pressure: 90 – 129 mmHg - Diastolic blood pressure: 60 – 84 mmHg - Pulse/Heart rate: 60 – 100 beats per minute (based on ESC - ESH Guidelines for the Management of Arterial Hypertension (2018)) 7. Subjects had no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening 8. Subjects had received the complete primary SARS CoV-2 vaccine 9. Subjects had negative result of SARS CoV-2 antigen test (for those who has not received the first booster vaccine)

Exclusion Criteria:

Any of the following criteria excluded the subject from the study: 1. those who were pregnant and/or nursing women (for women) 2. those with history of contraindication or hypersensitivity to sitagliptin, or allied drugs, or other ingredients in the study products, or a history of serious allergic reaction to any drug, significant allergic disease, or allergic reaction 3. those with a history or presence of medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, pancreatitis, diarrhea, gastric /intestinal surgery, renal insufficiency, hepatic dysfunction or any cardiovascular disease 4. those with history or presence of any coagulation disorder, or clinically significant hematology abnormalities 5. Those who disagreed to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse within study period 6. those who using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetics of the study drug, within two weeks prior to the drug administration day 7. those who participated in any clinical study within the past 90 days prior to the study 8. those who donated or losing 300 mL (or more) of blood within 3 months prior to the study 9. those who were smoker 10. those who had history of direct contact with a COVID-19 positive person in the subject’s neighborhood within 14 days prior to screening 11. those who had history or present of sore throat, fever (with temperature more than 37°C), cough, cold, anosmia/loss of smell, or dyspnea within the last 14 days 12. those who were positive to HIV, HBsAg, and HCV tests (to be kept confidential) 13. those who had history of drug or alcohol abuse within 12 months prior to screening for this study 14. those who were unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access
 
KET-570/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
Kristiawan Mardiansyah