NCT01053689

Bioequivalence Study of Dr.Reddys Laboratories Limited, Glimepiride 1 mg Tablets in Healthy Subjects Under Fed Condition

Randomized, 2-way Crossover, Bioequivalence Study of Glimepiride 1 mg Tablets and Amaryl 1 mg Tablets in Healthy Subjects Under Fed Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this bioequivalence study is to compare a test Glimepiride 1 mg tablets of Dr.Reddy's Laboratories Limited versus reference Amaryl 1 mg tablets of Aventis Pharmaceuticals Inc in healthy subjects, under fed condition.

Detailed description

The study was Single centre, randomized, single-dose, open-label,2-way crossover, bioequivalence study to compare a test Glimepiride 1 mg tablets of Dr.Reddy's Laboratories Limited versus Amaryl 1 mg tablets of Aventis Pharmaceuticals Inc in healthy subjects, under fed condition.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Glimepiride tablets 1 mg

Timeline

• Start date: 2003-12-01
• Primary completion: 2003-12-01
• Completion: 2003-12-01
• First posted: 2010-01-21
• Last updated: 2010-01-21

Locations

1 site across 1 country: Canada