Overview

GXR RM China BE Study (Darmstadt - Jiangsu)

Status:
Not yet recruiting
Trial end date:
2023-02-10
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Treatments:
Metformin