Bioequivalence study of Metformin 500 mg ( VARIOMET® 500 mg) manufactured by Faran pharmed
Not Applicable
- Conditions
- This study is performed on healthy volunteers and drug concentration in plasma is determined..
- Registration Number
- IRCT20200105046010N98
- Lead Sponsor
- Faran Pharmed company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
General Health (Liver, Heart, and Kidney)
Body Mass Index (18-30)
Informed consent
Age (18-55 years old)
Exclusion Criteria
Smoking
History of cardiovascular disease
Informed consent
Age (18-55 years old)
History of allergy to Metformin
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug plasma concentration. Timepoint: 0.5? 1? 1.5? 2? 2.5? 3? 3.5? 4? 4.5? 5? 6? 8? 10,12,24h after drug administration. Method of measurement: Liquid Chromatography Mass-Mass.
- Secondary Outcome Measures
Name Time Method Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.