Tahapan Penelitian : Complete
Mitra Pelaksana:
No Registry
Tanggal Input Registry : 30-08-2023

The value of 90 % confidence intervals of the ratio of the two main bioavailability parameters were as follow: 97.58 – 108.37% (102.83%) for Cmax Sitagliptin (Cmax mean ratio); 97.21 – 109.17% (103.02%) for Cmax Metformin (Cmax mean ratio); 101.04 – 108.38% (104.65%) for AUC0-t Sitagliptin (AUC0-t mean ratio); 96.74 – 107.00% (101.74%) for AUC0-t Metformin (AUC0-t mean ratio). The coefficient of variation intrasubject of the two main bioavailability parameters were as follow : 7.79% for Cmax Sitagliptin; 8.61% for Cmax Metformin; 5.21% for AUC0-t Sitagliptin; 7.49% for AUC0-t Metformin.
Bioequivalence study Combination of 50 mg Sitagliptin and 1000 mg Metformin Hydrochloride Film Coated Caplets, Manufactured by PT. Pharos Indonesia (Glivtin®) In Comparison with the Innovator’s Film Coated Tablets (Janumet®), Manufactured by Patheon Puerto Rico, Inc., USA, Released by Merck Sharp & Dohme BV Harleem, Netherlands, Registered by PT. Merck Sharp Dohme Pharma Tbk, Pandaan, Jawa Timur
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.

Inclusion Criteria:

Healthy male/female subjects determined by the medical screening assessments, aged 18-55 years of age, body mass index is in the range of 18-25 kg/m2, able to communicate well with the investigators and sign an informed consent, systolic blood pressure: 100-120 mmHg, diastolic blood pressure: 60-80 mmHg, pulse rate: 60-90 bpm, normal ECG, clinical laboratory results have to be within normal range.

Exclusion Criteria:

Pregnant or lactating women (urinary pregnancy test were applied to female subjects when screening and just before taking the study drug), known hypersensitivity or contraindication to the study drug, intake of any prescription drug or non-prescription drug/food supplement/herbal medicine within 7 days of this study’s first dosing day, history of any bleeding or coagulative disorders, any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal diseases including gastric or duodenal ulcers or history of gastric surgery, a donation or loss of 450 mL (or more) of blood within 3 months before this study’s first dosing day, a positive Hepatitis B surface antigen (HBsAg), HCV, HIV test result, history of drug or alcohol abuse within 12 months prior to this study, hard Smoker (more than 10 cigarettes a day), clinically have significant bleeding within 3 months prior to the study, participation in a previous study within 3 months of this study’s first dosing day.
MTA number
PPUK/PPUB number
Ni Made Dwi Wulandari, S.KM.