Bioequivalence study of Sitagliptin Phosphate ~ Sitagliptin 100 mg film coated tablet produced by PT Pratapa Nirmala in comparison with Januvia™ (Sitagliptin Phosphate ~ Sitagliptin 100 mg) film coated tablet manufactured by Organon Pharma (UK) Limited, England, registered and packed by PT Organon Pharma Indonesia Tbk., distributed by PT Merck Sharp & Dohme Indonesia.
Tahapan Penelitian : Complete
Sponsor:
PT Pratapa Nirmala
Mitra Pelaksana:
PT Omega Medika Farma Laboratori
No Registry
INA-19NDMAGE
Tanggal Input Registry : 12-03-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 01-02-2025 |
| Outcome Primer | AUCt and Cmax |
| Outcome Skunder | AUCinf, tmax, half-life |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence study of Sitagliptin Phosphate ~ Sitagliptin 100 mg film coated tablet produced by PT Pratapa Nirmala in comparison with Januvia™ (Sitagliptin Phosphate ~ Sitagliptin 100 mg) film coated tablet manufactured by Organon Pharma (UK) Limited, England, registered and packed by PT Organon Pharma Indonesia Tbk., distributed by PT Merck Sharp & Dohme Indonesia. |
| Judul Penelitian Ilmiah | Bioequivalence study of Sitagliptin Phosphate ~ Sitagliptin 100 mg film coated tablet produced by PT Pratapa Nirmala in comparison with Januvia™ (Sitagliptin Phosphate ~ Sitagliptin 100 mg) film coated tablet manufactured by Organon Pharma (UK) Limited, England, registered and packed by PT Organon Pharma Indonesia Tbk., distributed by PT Merck Sharp & Dohme Indonesia. |
| Jenis Penelitian | Interventional |
| Intervensi | Test drug : Sitagliptin Phosphate ~ Sitagliptin 100 mg film coated tablet produced by PT Pratapa Nirmala |
| Jumlah Subyek Penelitian | 16 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Willing to sign the informed consent; Age 18 – 55 years; Body mass index between 18 – 25 kg/m2; Normotensive (systolic blood pressure 100 – 120 mmHg, diastolic blood pressure 60 -80 mmHg), heart rate 60 – 100 beats per minute (as assessed through both pulse examination and ECG test results), respiration rate 12-20 x/minutes, body temperature < 37.3°C, Healthy male/female (healthy criteria is determined by normal values or if outside the normal range of values but no clinically significant effects based on doctors' justification on the result of laboratory test include routine hematology, liver function, renal function, blood sugar and urinalysis; history of disease, and physical examination), Willing to practice abstention or use non-hormonal contraception during the studyExclusion Criteria: Contraindicated and/or has history of hypersensitivity to Sitagliptin or related drug; With history or present medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction, or cardiovascular disease; Show abnormal result or not within the acceptance range (clinically significant effect based on doctor’s justification) in the electrocardiography (ECG) test results, Using any medication (prescription or non-prescription drug, food supplement, herbal medicine) within 7 days prior to the study; Participated in any clinical study within 3 months prior to the dosing day; Donated or lost 300 mL (or more) of blood within 3 months prior to the dosing day; Smoke more than 9 sticks of cigarettes a day; Have any bleeding or coagulation disorder; Indicate the positive result on test for HbsAg, Anti-HCV, and anti-HIV; pregnant or lactating female (urinary pregnancy test applied to female subjects at screening and before taking the study drug). |
| Administrative Information | |
| Nomor Persetujuan Etik | No. KET-17/ UN2.F1/ETIK/PPM.00.02/2025 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | Protocol No. 221/FORM/OMF/2024 ver 01 Report No. 169/RPT/OMF/2025 ver 00 |
| Contact Person | apt. Tasha Yuliandra, M.Sc |