NCT01373138

Bioequivalence Study of Desloratadine and Pseudoephedrine Sulfate Extended-release Tablets Under Fasting Conditions

Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Desloratadine and Pseudoephedrine 5 mg/240 mg Extended-Release Tablet and Clarinex-D® 24-Hour (Reference) Following a 5 mg/240 mg Dose in Healthy Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (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, 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-pseudoephedrine and Schering Corporation, U.S.A.(Clarinex-D® 24-HOUR), desloratadine-pseudoephedrine, administered as a 1 x 5 mg/240 mg extended-release tablet under fasting conditions. The treatment phases were separated by a washout period of 14 days. 34 subjects(19 males and 15 females) were dosed and were enrolled in the study; 31 of these enrolled subjects completed the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Desloratadine and pseudoephedrine	Desloratadine and pseudoephedrine 5/240 mg

Timeline

• Start date: 2006-04-01
• Completion: 2006-05-01
• First posted: 2011-06-14
• Last updated: 2011-06-14

Locations

1 site across 1 country: Canada