CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 38 enrolled
Drug / intervention
500 mg metformin hydrochloride extended release caplet (test drug) +1 moredrug
Likely dose
500 mg metformin hydrochloride extended release caplet (test drug)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01677260
NCT01677260N/ACompleted
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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.

Dexa Medica Group·interventional·Posted Aug 31, 2012·Updated Aug 31, 2012

In Brief

A clinical study evaluating 500 mg metformin hydrochloride extended release caplet (test drug) and 500 mg metformin hydrochloride prolonged release tablet (reference drug) for Metformin XR BE Study in Healthy Volunteers With Single and Multiple Dose. Completed, enrolled 38 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetformin XR BE Study in Healthy Volunteers With Single and Multiple Dose
CountriesIndonesia
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 31, 2012
Enrollment StartOct 1, 2009
Primary CompletionDec 1, 2009
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.8 years ago

Interventions

500 mg metformin hydrochloride extended release caplet (test drug)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.

500 mg metformin hydrochloride prolonged release tablet (reference drug)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.