Ignite Creation Date:
2024-05-05 @ 10:32 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01133470
Status:
COMPLETED
Last Update Posted:
2010-06-14
First Post:
2010-05-27
Brief Title:
Bioequivalence Study of Fexofenadine HCl 180 mg Pseudoephedrine HCl 240 mg ER Tablets of Dr Reddys and Allegra D 24 Hour ER Tablets Under Fasting Conditions
Sponsor:
Dr Reddys Laboratories Limited
Organization:
Dr Reddys Laboratories Limited
Study Overview
Official Title:
An Open Label Balanced Randomized Two-way Single Dose Crossover Bioequivalence Study of Fexofenadine HCl 180 mg Pseudoephedrine HCl 240 mg ER Tabs of Dr Reddys and Allegra-D 24 hr ER Tabs of Aventis in Healthy Subjects Under Fasting Conditions
Status:
COMPLETED
Status Verified Date:
2010-06
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:
The purpose of this study is to
1 Compare and evaluate the single dose crossover bioequivalence study of Fexofenadine HCl 180 mg Pseudoephedrine HCl 240 mg ER Tablets and Allegra-D 24 hr tablets
2 Monitor the adverse events and ensure the safety of subjects
1 Compare and evaluate the single dose crossover bioequivalence study of Fexofenadine HCl 180 mg Pseudoephedrine HCl 240 mg ER Tablets and Allegra-D 24 hr tablets
2 Monitor the adverse events and ensure the safety of subjects
Detailed Description:
An open label balanced randomized two-treatment two-period two-sequence single dose crossover bioequivalence study of Fexofenadine HCl 180 mg Pseudoephedrine HCl 240 mg ER Tablets of Dr Reddys and Allegra-D 24 hour ER Tablets of Aventis Pharmaceuticals Inc USA in healthy adult human subjects under fasting conditions
Study Oversight
Has Oversight DMC:
None
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?:
None