GXR RM China BE Study (Darmstadt - Jiangsu)

Phase 1 Completed 84 enrolled Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

RandomizedCrossoverOpen-labelOther

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.

Timeline

Start: 2022-07-25
Primary completion: 2023-01-03
Completion: 2023-01-03

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	500 mg	Oral

Indications

No indication recorded.