At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 48 enrolled

Drug / intervention

Glucophage XR (Test drug) +1 moredrug

Likely dose

Not stated in 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/NCT03583385

NCT03583385Phase 1Completed

Compare CT.gov

A Randomized, Open-label, Two-way Crossover Study Assessing the Bioequivalence (BE) Between Single Dose of 750 mg Glucophage® XR Tablets (PT Merck Tbk, Jakarta, Indonesia-Manufactured) and 750 mg Glucophage® XR Tablets (Merck Santé, Semoy, France-Manufactured) Under Fasted State in Healthy Subjects

Merck KGaA, Darmstadt, Germany·interventional·Posted Jul 11, 2018·Updated Nov 25, 2019

In Brief

A Phase 1 clinical trial evaluating Glucophage XR (Test drug) and Glucophage XR (Comparator drug) for Healthy. Completed, enrolled 48 participants across 1 site.

Detailed Summary

The purpose of this study is to assess bioequivalence between metformin hydrochloride (Glucophage® XR) manufactured in PT Merck Tbk, Indonesia (test drug) and metformin hydrochloride (Glucophage® XR) manufactured in Merck Santé, France (comparator drug) following single oral dose administration under fasting condition.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHealthy

CountriesIndonesia

Collaborators--

Timeline

Phase 1CompletedFinished

20192020202120222023202420252026

First PostedJul 2018

Enrollment StartAug 2018

Primary CompletionOct 2018

TodayJul 2026

First PostedJul 11, 2018

Enrollment StartAug 16, 2018

Primary CompletionOct 5, 2018

TodayJul 2, 2026

Enrollment to primary: 2 monthsPosted 8.0 years ago

Interventions

Glucophage XR (Test drug)drug

Participants received single oral dose of Glucophage® XR tablet manufactured by PT Merck Tbk, Jakarta, Indonesia (Test Drug) under fasted conditions.

Glucophage XR (Comparator drug)drug

Participants received single oral dose of Glucophage® XR tablet manufactured by Merck Santé, Semoy, France (Comparator Drug) under fasted conditions.