Bioequivalence study of two different Metformin formulations
- Conditions
- Health and normal volunteers.
- Registration Number
- IRCT20111107008022N9
- Lead Sponsor
- Sobhandarou
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Healthy male and female volunteers
Aged 18 to 45 years
Based on laboratory safety tests, no history of diseases affecting drug pharmacokinetic processes
lack of any chronic or acute medication at least 1 week before the start of the study
Actual weight (TBW) in the range of 20% IBW
Subject showed clinically relevant deviations from normal in physical examination
Subject had undergone surgery of the gastrointestinal tract
Subject had donated a unit of blood or participated in another clinical trial, within the last three months before the first treatment
Subject had a history of alcohol abuse or smokes more than 10 cigarettes per day
Use any medication within 14 days before the first treatment
A history of allergic to biguanides
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug plasma concentration. Timepoint: Blood samples were collected at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hour following drug administration. Method of measurement: Using High Performance Liquid Chromatography instrument.
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters. Timepoint: 0; 0.5; 1.0; 2.0; 3.0; 4.0; 4.5; 5.0; 5.5; 6.0; 6.5; 7.0; 8.0; 9.0; 10.0; 12.0; 16.0; 20.0; 24.0; 30.0 and 36 hours post-dose. Method of measurement: Drug analysis in plasma using a chromatographic apparatus and calculating pharmacokinetic parameters using pharmacokinetic models.