CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 81 enrolled
Drug / intervention
Glucophage® XR RM Test +1 moredrug
Likely dose
Glucophage® XR RM Test 500 mgfrom 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/NCT04684420
NCT04684420Phase 1Completed
CompareCT.gov

A Randomized Phase I, Open-Label, Active-Controlled Study Assessing The BE Between Single Doses of 500 mg GXR RM Tablets and 500 mg GXR Tablets Under Fasted and Fed State in Two 2-Way Crossover Groups of Healthy Participants

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany·interventional·Posted Dec 24, 2020·Updated Dec 29, 2023

In Brief

A Phase 1 clinical trial evaluating Glucophage® XR RM Test and Glucophage® XR Reference for Healthy. Completed, enrolled 81 participants across 1 site.

Detailed Summary

The purpose of this study was to assess bioequivalence (BE) of newly developed Glucophage® XR (GXR) reduced mass (RM) tablet (metformin hydrochloride 500 milligrams (mg) test tablet) and marketed Glucophage ® XR tablet (metformin hydrochloride 500 mg reference tablet) following single oral dose administration under fasted and fed conditions by comparing pharmacokinetics, safety and tolerability between test and reference in healthy participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesSouth Korea
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedDec 24, 2020
Enrollment StartDec 22, 2020
Primary CompletionMar 11, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.5 years ago

Interventions

Glucophage® XR RM Testdrug

Participants received a single oral dose of 500 mg of test Glucophage® XR RM tablet under fasting or fed conditions.

Glucophage® XR Referencedrug

Participants received a single oral dose of 500 mg of reference Glucophage® XR tablet under fasting or fed conditions.