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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Metformin Hydrochloride Extended-Release Tablets 750 mg once a day
GLUCOPHAGE®XR 750 mg once a day
Veeda Clinical Research Pvt. Ltd.
Ahmedabad, Gujarat, India
Bioequivalence is based on Cmax and AUC parameters.
Pre-dose \& at 1.00, 2.00, 3.00, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 20.00, 24.00, 30.00 and 36.00 hours post-dose.
Time frame: 1 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.