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

NCT01677260 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2012-08-31

No results posted yet for this study

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).

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Dexa Medica Group

    lead INDUSTRY

Principal Investigators

  • Danang A. Yunaidi, MD · PT Equilab International

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2009-12-31
Completion
2010-01-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01677260 on ClinicalTrials.gov