NCT01677260

Bioequivalence Study of Two Formulations of 500 mg Metformin Extended Release Tablet

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Metformin XR BE Study in Healthy Volunteers With Single and Multiple Dose

Interventions

Type	Name	Description
DRUG	500 mg metformin hydrochloride extended release caplet (test drug)	In each of the two study periods (separated by a washout of one week) a single and multiple dose of test or reference product was administered.
DRUG	500 mg metformin hydrochloride prolonged release tablet (reference drug)	In each of the two study periods (separated by a washout of one week) a single and multiple dose of test or reference product was administered.

Timeline

• Start date: 2009-10-01
• Primary completion: 2009-12-01
• Completion: 2010-01-01
• First posted: 2012-08-31
• Last updated: 2012-08-31

Locations

1 site across 1 country: Indonesia