NCT01677260

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.

Completed NA Last updated 30 August 2012

What this trial tests

NA trial testing 500 mg metformin hydrochloride extended release caplet (test drug) in Metformin XR BE Study in Healthy Volunteers With Single and Multiple Dose in 38 participants. Completed in 1 January 2010.

Timeline

1 October 2009

Primary endpoint
1 December 2009

1 January 2010

Quick facts

Lead sponsor	Dexa Medica Group
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	38
Start date	1 October 2009
Primary completion	1 December 2009
Estimated completion	1 January 2010
Sites	1 location across Indonesia

Drugs / interventions tested

• 500 mg metformin hydrochloride extended release caplet (test drug) — full drug profile →
• 500 mg metformin hydrochloride prolonged release tablet (reference drug) — full drug profile →

Conditions studied

• Metformin XR BE Study in Healthy Volunteers With Single and Multiple Dose — all drugs for Metformin XR BE Study in Healthy Volunteers With Single and Multiple Dose →

Sponsor

Dexa Medica Group — full company profile →

Who can join

Adults 18 to 55, any sex, with Metformin XR BE Study in Healthy Volunteers With Single and Multiple Dose. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Bioavailability
  Time frame: 24 hours
  Relative bioavailability (primarily measured by AUC and Cmax) between metformin hydrochloride 500 mg extended release caplet (test formulation) and metformin hydrochloride 500 mg prolonged release tablet (reference formulation) at a single dose.
• Bioavailability
  Time frame: 5 days
  Relative bioavailability (primarily measured by AUC and Cmax) between metformin hydrochloride 500 mg extended release caplet (test formulation) and metformin hydrochloride 500 mg prolonged release tablet (reference formulation)at multiple doses.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.