Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Extended Release Metformin and Extended Release Glimepiride in Health Volunteers

PHASE1

Phase

TERMINATED

Status

Enrollment

INDUSTRY

Sponsor class

Stopped Due to changes in EMA guidelines on modified release dosage forms (Feb 2013; EMA/CHMP/EWP/280/96). The Part B formulation would not meet the new guidelines.

Conditions

Diabetes Mellitus, Type 2

Interventions

DRUG: Metformin, 500 mg extended release tablet
DRUG: Metformin, 1000 mg extended release tablet
DRUG: Glimepiride, 1 mg immediate release tablet
DRUG: Glimepiride, 2 mg immediate release tablet
DRUG: Metformin, 500 mg and Glimepiride, 1 mg extended release film coated tablet containing release controlling polymers
DRUG: Metformin, 1000 mg and Glimepiride, 2 mg extended release film coated tablet containing release controlling polymers
DRUG: Metformin, 500 mg and Glimepiride, 1 mg extended release tablet coated with release controlling polymers
DRUG: Metformin, 1000 mg and Glimepiride, 2 mg extended release tablet coated with release controlling polymers

Sponsor

GlaxoSmithKline