NCT01506050

Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fasting Condition

Randomized, Single Dose, 2-Way Crossover, Relative Bioavailability Study of Desloratadine Orally Disintegrating Tablet Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an open label, randomised, single dose, 2-way crossover, comparative bioequivalence study.

Detailed description

The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Laboratories Ltd., India, desloratadine ODT 5 mg and Schering Corporation, U.S.A.(Clarinex® 5 mg), desloratadine ODT 5 mg under fasting conditions. The treatment phases were separated by a washout period of 14 days. 38 subjects were dosed and were enrolled in the study; 35 of these enrolled subjects completed the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Desloratadine	Desloratadine ODT 5 mg

Timeline

• Start date: 2006-01-01
• Completion: 2006-02-01
• First posted: 2012-01-09
• Last updated: 2012-01-09

Locations

1 site across 1 country: United States