The purpose of this study is 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.
Phase:
Phase 1
Details
Lead Sponsor:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany