Bioequivalence Study of Sitagliptin Phosphate Monohydrate 100 mg Film-Coated Tablet Produced by PT Kimia Farma Tbk Compared to JanuviaTM 100 mg Film-Coated Tablet Produced by Organon Pharma (UK) Limited, Cramlington, England, Registered and Packed by PT. Organon Pharma Indonesia Tbk, Pasuruan Indonesia.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
EQuitrust Lab - PT Kimia Farma Diagnostika
No Registry
INA-65MY8QZE
Tanggal Input Registry : 18-06-2025

09-05-2025
AUC0-t , Cmax
AUC0-inf , tmax, half life
 
Bioequivalence Study of Sitagliptin Phosphate Monohydrate 100 mg Film-Coated Tablet Produced by PT Kimia Farma Tbk Compared to JanuviaTM 100 mg Film-Coated Tablet Produced by Organon Pharma (UK) Limited, Cramlington, England, Registered and Packed by PT. Organon Pharma Indonesia Tbk, Pasuruan Indonesia.
Bioequivalence Study of Sitagliptin Phosphate Monohydrate 100 mg Film-Coated Tablet Produced by PT Kimia Farma Tbk Compared to JanuviaTM 100 mg Film-Coated Tablet Produced by Organon Pharma (UK) Limited, Cramlington, England, Registered and Packed by PT. Organon Pharma Indonesia Tbk, Pasuruan Indonesia.
Interventional
Sitagliptin Phosphate Monohydrate 100 mg Film-Coated Tablet Produced by PT Kimia Farma Tbk
20
 

Inclusion Criteria:

The inclusion criteria for this study include: 1) Signed informed consent; 2) Healthy based on clinical laboratory tests (routine hematology, liver function, kidney function, blood glucose, urinalysis, hepatitis B (HBsAg), hepatitis C (Anti-HCV) and HIV (Anti-HIV), medical history, and physical examination); 3) Male and female subjects (if female, consider the risks for women of childbearing age and perform pregnancy tests); 4) Age between 18-55 years; 5) Normal weight range according to Body Mass Index (BMI) 18-25 kg/m2 ); 6) Vital signs within the following ranges: systolic blood pressure 100- 129 mmHg, diastolic blood pressure 60-84 mmHg, normal pulse rate and heart rate (for ECG examination) 60-90 bpm, oxygen saturation (SpO2) in the normal range of 95- 100%, body temperature 36.5- 37.5oC, and normal respiratory rate of 12- 20/min.

Exclusion Criteria:

The exclusion criteria for this study include: 1) Smoking more than 10 cigarettes per day; 2) Pregnant or breastfeeding women. Pregnancy tests will be performed during screening and prior to the administration of the investigational or comparator drug; 3) History of kidney or liver disease, or history of allergy, hypersensitivity or contraindication to the investigational bioequivalence drug (Sitagliptin Phosphate Monohydrate); 4) Clinically significant (routine hematology, liver function, kidney function, blood glucose, urinalysis) abnormalities; 5) Abnormal electrocardiogram (ECG); 6) Difficulty accessing veins in the left or right arm; 7) History of significant ongoing clinically or medically significant chronic or acute illness; 8) History of drug or alcohol abuse within the past 12 months (1 year) prior to screening for this study; 9) Positive serology test results for Hepatitis B (HBsAg), Hepatitis C (anti-HCV), HIV (anti-HIV); 10) History or condition that can affect drug kinetics; 11) Use of drugs or dietary supplements no more than 7 days since the start of the study; 12) Participation in previous clinical trials no more than 3 months from the start of the study. The check is conducted using the checksubject.com system based on national identity number; 13) Blood donation or blood loss of more than 300 ml within 3 months from the start of the study.
 
KET-168/UN2.F1/ETIK/PPM.00.02/2025
Not applicable
PPUK/PPUB number
NA
Bayu Hadi Wahyono, Pharm, B.Pharm, MPH - Study Coordinator (+62 821 2559 0521 - lab.equitrust@gmail.com)