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Clinical trial

A Randomized, Open Label, Two-treatment, Two -Period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study of Metformin Hydrochloride Extended-Release Tablets USP 750 mg of Ipca Laboratories Ltd, India and GLUCOPHAGE®XR (Metformin HCl Extended-release Tablets) 750 mg of Bristol-Myers Squibb Company, USA in Normal, Healthy, Adult, Human Subjects Under Fasting Condition

NCT01831661 is registered in ClinicalTrials.gov with IPCA Laboratories Ltd. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized, Open Label, Two-treatment, Two -Period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study of Metformin Hydrochloride Extended-Release Tablets USP 750 mg of Ipca Laboratories Ltd, India and GLUCOPHAGE®XR (Metformin HCl Extended-release Tablets) 750 mg of Bristol-Myers Squibb Company, USA in Normal, Healthy, Adult, Human Subjects Under Fasting Condition
Lead sponsor
IPCA Laboratories Ltd.
Phase
Phase 1
Overall status
Completed
Start date
December 31, 2012
Completion date
February 28, 2013
Enrollment
48 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

fasting