Bio equivalence study of metformin 500 mg
Not Applicable
- Conditions
- Bioequivalence metformin 500 mg.
- Registration Number
- IRCT20200513047423N1
- Lead Sponsor
- Sana Med
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Healthy liver
Healthy kidney
observing BMI
Exclusion Criteria
Out of age ranges
No smoker
unhealthy liver and kidney
pregnancy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Increasing plasma concentration after administration of metformin tablets till Tmax and then decreasing plasma concentration after Tmax. Timepoint: Initial blood sampling is performed before drug administration to obtain blank plasma chromatogram of each healthy volunteers. Hence the Tmax of metformin is between 1.5 and 3 hours, so it is needed to have 5 blood samplings before Tmax. This period of time is called absorption phase. In the elimination phase (after Tmax) blood sampling carry out each hours. As in some articles it is mentioned that Tmax of metformin is around 3 hours so the blood samples should be collected in 24 hours. Method of measurement: In this study, the variable is plasma concentration of metformin. High performance liquid chromatography is used to determine the concentration of metformin in plasma.
- Secondary Outcome Measures
Name Time Method