NCT00775996

Bioequivalence Study of Clorazepate Dipotassium 15mg Tablets Under Fasting Conditions

The Objective of This Study Was to Compare the Single-Dose Relative Bioavailability of Ranbaxy and Abbott (Tranxene® T-Tab®) 15 mg Clorazepate Dipotassium Tablets Under Fasting Conditions.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Abbott (TranxeneeT-Tab®) 15 mg clorazepate dipotassium tablets under fasting 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 clorazepate dipotassium comparing clorazepate dipotassium 15mg tablets of Ranbaxy Laboratories with Abbott (TranxeneeT-Tab®) 15 mg, in healthy, adult, human, subjects under fasting conditions. A total of 32 subjects, 25 males and 7 females, were enrolled in the study, and 31 subjects, 24 males and 7 females, completed the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Clorazepate Dipotassium 15mg Tablets

Timeline

• Start date: 2003-08-01
• Primary completion: 2003-09-01
• Completion: 2003-11-01
• First posted: 2008-10-20
• Last updated: 2008-10-20

Locations

1 site across 1 country: United States