IRCT20111107008022N7
Recruiting
未知
Comparative bioequivalence study of two different Metformin 1000mg formulations (Reihaneh Pharmaceutical Company & reference) in 24 Iranian volunteers
Reihaneh Pharmaceutical Company0 sites24 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Reihaneh Pharmaceutical Company
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 consentactual
- •Weight (TBW) in the range of 20% IBW
Exclusion Criteria
- •Subject showed clinically relevant deviations from normal in physical examination
- •Subject had undergone surgery of the gastro\-intestinal 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
Outcomes
Primary Outcomes
Not specified
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