COMPOUND (INN): HOE490O - GLIMEPIRIDE / METFORMIN HCl (Amaryl® M)0 (Glimepiride/Metformin Hydrochloride Immediate Release Combination Tablet) in Fed Conditions in Healthy Male and/or Female Subjects.

Phase 1 Withdrawn Pharmaceutical Research Unit, Jordan Sanofi · collab

RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to assess, after single oral administration under fed conditions, the bioequivalence between the two batches of the same glimepiride/metformin hydrochloride (HCl) 2 mg/1000 mg fixed dose combination (FDC) tablets (immediate release combination tablet Amaryl® M IR 2/1000) manufactured in India and in Turkey.

Timeline

Start: 2015-05
Primary completion: 2015-05
Completion: 2015-12

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Glimepiride	Small molecule	2 mg	Oral
Subject	Metformin	Small molecule	1000 mg	Oral

Indications

No indication recorded.