Bioequivalance study of Metformin 1000 mg Tablets
Not Applicable
- Conditions
- Bioequivalance Metformin 1000 mg.
- Registration Number
- IRCT20200513047423N8
- Lead Sponsor
- Sana Med
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Healthy liver
Healthy kidney
Volunteers should not be too fat or too thin and their weight index should be in the appropriate range
Exclusion Criteria
Out of age ranges
smoking
pregnancy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentration changing after administration of Metformin 1000 mg tablet.Plasma concentration of Metformin at Tmax reaches about 1800 ng/mL and its measurement range is from 25ng / mL to 3000ng / mL. Timepoint: Initial blood sampling is performed before drug administration to obtain blank plasma chromatogram of each volunteers. Hence the Tmax of Metformin is between 1.5 and 3 hours, so it is needed to have 5 blood sampling before Tmax. This period of time is called absorption phase. In the elimination phase (after Tmax) blood sampling carry out each hours. Sampling is done in 10 and 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