Study of absorption and elimination rate of sitagliptin 50 mg tablets in comparison with standard tablets of Sitagliptin (Xelevia®).
Not Applicable
Recruiting
- Conditions
- En In this study, the disease is not examined. The subject of the study is the bioequivalence study of the Sitagliptin 50 mg of test and reference in healthy volunteers..
- Registration Number
- IRCT20200407046981N15
- Lead Sponsor
- Daana pharmaceutical company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
The weight limit for each volunteer is between 60 and 100 kg.
They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed.
Exclusion Criteria
Known hypersensitivity or idiosyncratic reaction to Sitagliptin or any ingredients.
Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg.
Regular smoker who smokes more than ten cigarettes daily.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax). Timepoint: At 0 (before dosing), 1? 2? 2.5? 3? 3.5? 4? 4.5? 5? 6? 8? 10? 12? 24 and 48 hour after dosing. Method of measurement: High-performance liquid chromatography—mass spectrometry (HPLC-MS).
- Secondary Outcome Measures
Name Time Method AUC (Area Under the Concentration-Time Curve). Timepoint: At 0 (before dosing), 1? 2? 2.5? 3? 3.5? 4? 4.5? 5? 6? 8? 10? 12? 24 and 48 hour after dosing. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS.