Metformin XR BE Study in Healthy Volunteers With Single and Multiple Dose Clinical Trial
Official title:
A Combined Single Dose Study Under Fasting Condition And Multiple Doses Study Under Normal Diabetic Meal Comparing the Bioavailability of Two Formulations of 500 mg Metformin Hydrochloride Extended Release Tablets.
This was a single centre, single-blind, randomized, balanced, combined single dose study under fasting condition and multiple doses study under fed condition with normal diabetic-meal, two-period, two-sequence cross-over study to to compare the bioavailability of metformin hydrochloride 500 mg extended release caplet (test drug) and metformin hydrochloride 500 mg prolonged release tablet (reference formulation).
On Day 1, to obtain pharmacokinetic profile of a single dose, the test or reference drugs
were given with 200 mL of water and swallowed without chewing the drug. For multiple doses
administration at Day 2 until Day 5, the study drugs were administered at a regimen of one
tablet each day, 30 minutes after breakfast. Time of drug administration was standardized
for all participating subjects throughout the study period.
From each subject, on Day 1 until Day 5 blood samples were drawn 5 mL before breakfast and
drug administration; and breakfast was provided only on Day 2 until Day 5. Only on Day 1 and
Day 5 after drug administration, the blood samples were drawn 5 mL each at 1, 1.5, 2, 2.5,
3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12, 16 and 24 hours.
The blood samples drawn on Day 1 were used to show the single dose pharmacokinetic profile
under fasting condition; while those drawn on Day 5 were used to show the
multiple-dose-pharmacokinetic profile after meal intake.
One week after the first drug administration (washout period), the same procedure was
repeated with the alternate drug.
The plasma concentrations of metformin were determined by high performance liquid
chromatography with ultraviolet detection (HPLC-UV). The pharmacokinetic parameters assessed
in the single dose study were AUCt, AUCinf, Cmax, tmax, and t1/2. The pharmacokinetic
parameters assessed in multiple doses study at steady state phase were AUCtau, Cmax, Cmin,
and t1/2.
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Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment