NCT05463094

GXR RM China BE Study (Darmstadt - Jiangsu)

A Randomized, Open-label, 2-Way-Crossover Study Assessing the Bioequivalence Between Single Doses of 500 mg Glucophage® XR RM Tablets (Merck/China Jiangsu-Manufactured) and 500 mg Glucophage® XR RM Tablets (Merck/Germany Darmstadt-Manufactured) Under Fed and Fasted State in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess Bioequivalence (BE), pharmacokinetics (PK), safety and tolerability following single oral dose administrations between a Glucophage Extended Release, Reduced Mass (Glucophage XR RM) manufactured in Merck Jiangsu China (test product) and that manufactured in Merck Darmstadt Germany (reference product) administered under fasted and fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Test Glucophage® XR	Participants will receive single oral dose of Test GXR RM tablet under fasted or fed conditions.
DRUG	Reference Glucophage® XR	Participants will receive single oral dose of Reference GXR RM tablet under fasted or fed conditions.

Timeline

• Start date: 2022-07-25
• Primary completion: 2023-01-03
• Completion: 2023-01-03
• First posted: 2022-07-18
• Last updated: 2023-04-14

Locations

1 site across 1 country: Germany