Bioequivalence Study of 100 mg Sitagliptin Tablets, Manufactured by PT Lapi Laboratories (Glutin®) in Comparison with The Innovator's Tablets (Januvia®) Manufactured by Merck Sharp & Dohme Ltd., Shotton Lane, Cramlington, Northumberland NE23 3JU, England, Registered and Packaged by PT Merck Sharp Dohme Pharma Tbk., Pandaan, Jawa Timur
Tahapan Penelitian : Complete
Sponsor:
PT Lapi Laboratories
Mitra Pelaksana:
Econolab
No Registry
INA-Y0WKZE6
Tanggal Input Registry : 27-05-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 07-12-2018 |
| Outcome Primer | AUC0-t, Cmax |
| Outcome Skunder | AUC0-inf, Tmax, T1/2 |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of 100 mg Sitagliptin Tablets, Manufactured by PT Lapi Laboratories (Glutin®) in Comparison with The Innovator's Tablets (Januvia®) Manufactured by Merck Sharp & Dohme Ltd., Shotton Lane, Cramlington, Northumberland NE23 3JU, England, Registered and Packaged by PT Merck Sharp Dohme Pharma Tbk., Pandaan, Jawa Timur |
| Judul Penelitian Ilmiah | Bioequivalence Study of 100 mg Sitagliptin Tablets, Manufactured by PT Lapi Laboratories (Glutin®) in Comparison with The Innovator's Tablets (Januvia®) Manufactured by Merck Sharp & Dohme Ltd., Shotton Lane, Cramlington, Northumberland NE23 3JU, England, Registered and Packaged by PT Merck Sharp Dohme Pharma Tbk., Pandaan, Jawa Timur |
| Jenis Penelitian | Interventional |
| Intervensi | Single dose of 100 mg Sitagliptin Tablets (Glutin®), Manufactured by PT Lapi Laboratories |
| Jumlah Subyek Penelitian | 14 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Able to communicate well with the investigators and agree to sign an informed consent; Healthy male/female subjects as determined by the medical screening assessments; Aged 18-55 years; Body mass index (BMI) is in the range of 18-25 kg/m²; Normal blood pressure (systolic 100-120 mmHg; diastolic 60-80 mmHg); Normal pulse rate (60-90 bpm); Normal electrocardiogram (ECG); Clinical laboratory results must be within normal range. The abnormal results have been justified by physician.Exclusion Criteria: Pregnant or lactating women (urinary pregnancy test were applied to female subjects when screening and just before taking the test or reference drug); Known hypersensitivity or contraindication to the study drug; Intake of any prescription drug or non-prescription drug/food supplement/herbal medicine within seven (7) days of this study’s first dosing day; History of any bleeding, or coagulation disorders; Any surgical or medical condition (present or history) which might significantly alters 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 three (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 twelve (12) months prior to the study; Heavy smoker (more than 10 cigarettes a day); Had clinically significant bleeding within three (3) months prior to the study; Participation in a previous study within three (3) months of this study’s first dosing day |
| Administrative Information | |
| Nomor Persetujuan Etik | 180/UN2.F1/ETIK/2017 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | PRO-218/17/ECL |
| Contact Person | Ni Made Dwi Wulandari |