Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-29 @ 3:12 AM
Study NCT ID:
NCT01506050
Status:
COMPLETED
Last Update Posted:
2012-01-09
First Post:
2012-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fasting Condition
Sponsor:
Dr. Reddy's Laboratories Limited
Organization:
Study Overview
Official Title:
Randomized, Single Dose, 2-Way Crossover, Relative Bioavailability Study of Desloratadine Orally Disintegrating Tablet Fasting Conditions
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: