Bioequivalence study of Sitagliptin 100mg tablet of Abureihan Pharm Co., IRA
- Conditions
- Diabet.
- Registration Number
- IRCT20190706044111N5
- Lead Sponsor
- Aburaihan Pharm Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
Aged between 20 - 50 years
body weight between 50 – 100 kg
Having good health on the basis of medical history and physical & clinical examination.
Understand the procedures and give written informed consent.
Subject showed clinically relevant deviations from normal in physical examination.
Subject had undergone surgery of the gastro-intestinal tract
Subject had donated a unit of blood or participated in another clinical trial, within the last 8 weeks before the first treatment.
Subject had a history of drug or alcohol abuse. Subject who smokes more than 10 cigarettes per day.
Subject had used any prescription medication within 14 days, or any non-prescription medication within 7 days, before the first treatment.
Subject had a history of allergic to sitagliptine
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentration of Sitagliptine. Timepoint: Plasma related to 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 & 36 hr. after dosing. Method of measurement: HPLC.
- Secondary Outcome Measures
Name Time Method