Bioequivalence Study of 100 mg Sitagliptin Film-Coated Film-coated tablets Manufactured by PT. Tropica Mas Pharmaceuticals in Comparison with 100 mg Januvia™ Film-Coated Film-coated tablets Manufactured by Merck Sharp & Dohme Ltd., Cramlington, England, Registered and Packed by PT. Merck Sharp Dohme Pharma Tbk, Pasuruan, Indonesia
Tahapan Penelitian : Complete
Sponsor:
PT. Tropica Mas Pharmaceuticals
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-H7BTHKZ
Tanggal Input Registry : 10-01-2024
Tracking Information | |
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Tanggal Antisipasi Studi | 16-05-2022 |
Outcome Primer | Cmax and AUCt |
Outcome Skunder | |
Descriptive Information | |
Judul Penelitian Popular | Bioequivalence Study of 100 mg Sitagliptin Film-Coated Film-coated tablets Manufactured by PT. Tropica Mas Pharmaceuticals in Comparison with 100 mg Januvia™ Film-Coated Film-coated tablets Manufactured by Merck Sharp & Dohme Ltd., Cramlington, England, Registered and Packed by PT. Merck Sharp Dohme Pharma Tbk, Pasuruan, Indonesia |
Judul Penelitian Ilmiah | Bioequivalence Study of 100 mg Sitagliptin Film-Coated Film-coated tablets Manufactured by PT. Tropica Mas Pharmaceuticals in Comparison with 100 mg Januvia™ Film-Coated Film-coated tablets Manufactured by Merck Sharp & Dohme Ltd., Cramlington, England, Registered and Packed by PT. Merck Sharp Dohme Pharma Tbk, Pasuruan, Indonesia |
Jenis Penelitian | Interventional |
Intervensi | Sitagliptin 100 mg film-coated tablets |
Jumlah Subyek Penelitian | 20 |
Recruitment Information | |
Eligibility Criteria | Inclusion Criteria: Healthy male or female subjects, subject had read the subject information and signed informed consent documents, age range of subject from 18 – 55 years, body mass index between 18 – 25 kg/m2, subject had a normal electrocardiogram, subject had the blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg), subject had the heart rate within normal range (60 – 100 bpm), subject had absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening, subject agreed to use protection (condom) before any intercourse with their spouse throughout the studyExclusion Criteria: Those who were pregnant and/or nursing women, those with history of contraindication or hypersensitivity to sitagliptin , or other antidiabetic agent, or other ingredients in the study products, or a history of serious allergic reaction to any drug, a significant allergic disease or allergic reaction, those with a history or presence of medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease, those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities, those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day, those who participated in any clinical study within 3 months prior to the study ( |
Administrative Information | |
Nomor Persetujuan Etik | KET-89/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 | 649/STD/PML/2021 |
Contact Person | Nabila Mudin Sutanto |