Fasting Clinical Trial
Official 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
The study was a randomized, open label, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in normal, healthy adult human subjects under fasting condition.
Objective of the study is to compare and evaluate the single-dose oral bioavailability 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.
Total duration of the study was of 17 days from the day of admission of first period till
the end of second period.
Upon entering into the study, subjects were housed in clinical facility of Veeda Clinical
Research Pvt. Ltd. to ensure 10 hours overnight fasting before dosing and continued to be
housed in the facility till 36.00 hours post-dose blood sample collection in each of the two
periods.
A gap of 14 days was kept as wash out between each consecutive dosing period.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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