NCT00776620

Bioequivalence Study of Glimepiride 1mg Tablets Under Fed Conditions

A Relative Bioavailability Study of Glimepiride 1 MG Tablets Under Fed Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the relative bioavailability of glimepiride 1 mg tablets (manufactured by Ranbaxy Laboratories Limited) with that of AMARYL® 1 mg tablets (following a single oral dose (1 x 1 mg tablet) in healthy, adult subjects under fed conditions.

Detailed description

The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on glimepiride comparing glimepiride 1mg tablets of Ranbaxy laboratories limited with Amaryl 1mg tablets of in healthy, adult, human, subjects under fed conditions. Thirty-two (32) subjects were recruited for this study and all subjects were healthy adults. Thirty-two (32) subjects began the study, and thirty-two (32) completed the clinical portion of the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Glimepiride 1mg Tablets

Timeline

• Start date: 2003-07-01
• Primary completion: 2003-08-01
• Completion: 2003-09-01
• First posted: 2008-10-21
• Last updated: 2008-10-21

Locations

1 site across 1 country: United States