NCT04684420

GXR RM (Glucophage® Extended Release Reduced Mass) 500 Milligram (mg) Korea Bioequivalence (BE) Study

A Randomized Phase I, Open-Label, Active-Controlled Study Assessing The BE Between Single Doses of 500 mg GXR RM Tablets and 500 mg GXR Tablets Under Fasted and Fed State in Two 2-Way Crossover Groups of Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Glucophage® XR RM Test	Participants received a single oral dose of 500 mg of test Glucophage® XR RM tablet under fasting or fed conditions.
DRUG	Glucophage® XR Reference	Participants received a single oral dose of 500 mg of reference Glucophage® XR tablet under fasting or fed conditions.

Timeline

• Start date: 2020-12-22
• Primary completion: 2022-03-11
• Completion: 2022-03-11
• First posted: 2020-12-24
• Last updated: 2023-12-29
• Results posted: 2023-12-29

Locations

1 site across 1 country: South Korea