Bioequivalence study of Gluditin (Sitagliptin 100 mg) film coated tablet produced by PT Konimex in Comparison with Januvia (Sitagliptin 100 mg) tablet manufactured by Merck Sharp & Dohme Ltd., England, imported by PT Merck Sharp Dohme Pharma Tbk., Indonesia.
Tahapan Penelitian : Complete
Sponsor:
PT Konimex
Mitra Pelaksana:
PT Omega Medika Farma Laboratori
No Registry
INA-GBE4Z3D
Tanggal Input Registry : 29-05-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 05-11-2022 |
| Outcome Primer | AUCt and Cmax |
| Outcome Skunder | AUCinf, tmax, half-life |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence study of Gluditin (Sitagliptin 100 mg) film coated tablet produced by PT Konimex in Comparison with Januvia (Sitagliptin 100 mg) tablet manufactured by Merck Sharp & Dohme Ltd., England, imported by PT Merck Sharp Dohme Pharma Tbk., Indonesia. |
| Judul Penelitian Ilmiah | Bioequivalence study of Gluditin (Sitagliptin 100 mg) film coated tablet produced by PT Konimex in Comparison with Januvia (Sitagliptin 100 mg) tablet manufactured by Merck Sharp & Dohme Ltd., England, imported by PT Merck Sharp Dohme Pharma Tbk., Indonesia. |
| Jenis Penelitian | Interventional |
| Intervensi | |
| 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 – 90 beats per minute; Healthy male (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 glucose, and urinalysis; history of disease, and physical examination)Exclusion 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; Using any medication (prescription or non-prescription drug, food supplement, herbal medicine) within 7 days prior to the dosing day; Participated in any clinical study within 3 months prior to the study; Donated or lost 300 mL (or more) of blood within 3 months prior to the study; 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; With the history of alcohol and drug abuse; If the study is conducted in Covid-19 pandemic situation, the exclusions criteria below must be applied: a. With history of direct contact with a Covid-19 positive person within last 14 days; With history or present sore throat, fever (temperature more than 37°C) or short of breath within last 14 days; Positive to Covid-19 antigen rapid test. |
| Administrative Information | |
| Nomor Persetujuan Etik | No. KET-1068/ UN2.F1/ETIK/PPM.00. 02/2022 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | Protocol No. 147/FORM/OMF/2022 ver 01 Report No. 115/RPT/OMF/2022 ver 00 |
| Contact Person | apt. Tasha Yuliandra, M.Sc. |