Bioequivalency study of two different Metformin formulations

Not Applicable

Recruiting

Conditions: Health and normal volunteers.
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Registration Number: IRCT20111107008022N5

Lead Sponsor: Kushan Pharmed Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

24 healthy male and female volunteers will participate in this study. 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, adherence to the criteria on the basis of moral obligation and signed an informed consent; actual weight (TBW) in the range of 20% IBW Exclusion criteria: Age outside the range mentioned; acute or chronic smoking or alcohol, failure to obtain any of the above health tests, medication two weeks before the experiment

Exclusion Criteria

Not provided

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 h following drug administration. Method of measurement: Using HPLC 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.