NCT01728740

Bioequivalence Study for Acarbose / Metformin FDC

Randomized, Non-blinded Crossover Study to Establish the Bioequivalence Between Fixed Dose Combination (FDC) and Loose Combination of Acarbose and Metformin and to Investigate the Potential for a Drug-drug Interaction Following Single Oral Dosing in Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).

Conditions

• Diabetes Mellitus, Type II

Interventions

Type	Name	Description
DRUG	Acarbose/Metformin FDC (BAY81-9783)	Acarbose/Metformin FDC (BAY81-9783)50mg/500mg, oral, single dose
DRUG	Acarbose (Glucobay, BAYG5421)	Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose
DRUG	Metformin	Metformin 500mg, oral, single dose

Timeline

• Start date: 2012-09-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-11-20
• Last updated: 2012-12-19

Locations

1 site across 1 country: South Korea