CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 54 enrolled
Drug / intervention
Test GXR +1 moredrug
Likely dose
Test GXR 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/NCT03566810
NCT03566810Phase 1Completed
CompareCT.gov

A Randomized, Open-label, 2-Way-Crossover Study Assessing the Bioequivalence Between Single Doses of 500 mg Glucophage Extended Release (GXR) Tablets (Merck/China Nantong-Manufactured) and 500 mg GXR Tablets (Merck/Germany Darmstadt-Manufactured) Under Fed and Fasted State in Two Groups of Healthy Volunteers

Merck KGaA, Darmstadt, Germany·interventional·Posted Jun 25, 2018·Updated Jan 9, 2020

In Brief

A Phase 1 clinical trial evaluating Test GXR and Reference GXR for Healthy. Completed, enrolled 54 participants across 1 site.

Detailed Summary

The study will assess the bioequivalence between single doses of GXR manufactured in Merck Nantong China (test drug) and GXR manufactured in Merck Darmstadt Germany (reference drug) under fed and fasted state in healthy participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJun 25, 2018
Enrollment StartOct 11, 2018
Primary CompletionNov 28, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.0 years ago

Interventions

Test GXRdrug

Participants received a single oral dose of 500 mg of test GXR tablet (Merck Nantong/China) under fasting or fed conditions on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2).

Reference GXRdrug

Participants received a single oral dose of 500 mg of reference GXR tablet (Merck Darmstadt/France) under fasting or fed conditions on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2).