An interventional study of metformin HC1 750 mg extended-release tablets in Healthy, sponsored by Ranbaxy Laboratories Limited. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-10-23.
Sponsored by Ranbaxy Laboratories Limited · Not applicable and Interventional
The objective of this study is to compare the relative bioavailability of metformin HC1 750 mg extended-release tablets (Ranbaxy) with that of Glucophage® XR 750 mg tablets (Bristol Myers Squibb) in healthy, adult, subjects under fasting conditions.
This study was randomised, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study planned on 60 healthy, adult, subjects under fasting conditions. 60 subjects were enrolled and 55 subjects completed all the periods of the study. Both periods were separated by a washout period of fourteen days A total of Sixty (60) subjects were enrolled in this study; 55 completed the study.
Ranbaxy Laboratories Limited is the lead sponsor of 97 studies on the registry; none are open to participants now.
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Exclusion Criteria:
All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study
metformin HC1 750 mg extended-release tablets
Drug: metformin HC1 750 mg extended-release tablets
Glucophage® XR 750 mg tablets
Drug: metformin HC1 750 mg extended-release tablets
Bioequivalence
This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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Ranbaxy Laboratories Limited