Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT01066767
Status:
COMPLETED
Last Update Posted:
2010-02-10
First Post:
2010-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Dr. Reddy's Laboratories Limited Fexofenadine Hydrochloride 180 mg Tablets Under Fed Conditions
Sponsor:
Dr. Reddy's Laboratories Limited
Organization:
Study Overview
Official Title:
Randomized, 2-Way Crossover, Bioequivalence Study of Fexofenadine Hydrochloride 180 mg Tablets and Allegra® 180 mg Tablets Administered as 1 x 180 mg Tablet in Healthy Subjects Under Fed Conditions
Status:
COMPLETED
Status Verified Date:
2010-02
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:
Randomized, 2-Way Crossover, Bioequivalence Study of Fexofenadine Hydrochloride 180 mg Tablets of Dr.Reddy's Laboratories Limited, and Allegra® 180 mg Tablets aventis Administered as
1 x 180 mg Tablet in Healthy Subjects under Fed Conditions
1 x 180 mg Tablet in Healthy Subjects under Fed Conditions
Detailed Description:
The objective of this study is to compare the rate and extent of absorption of fexofenadine hydrochloride 180 mg tablets (test) versus Allegra® (reference) administered as 1 x 180 mg tablet under fasting conditions. Single oral dose (1 x 180 mg) in each period with a washout of at least 7 days between doses.
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?: