Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-27 @ 9:23 AM
Study NCT ID:
NCT00973050
Status:
COMPLETED
Last Update Posted:
2009-09-09
First Post:
2009-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Bicalutamide 1 x 50 mg Tablet in Healthy Subjects Under Fasting Conditions
Sponsor:
Teva Pharmaceuticals USA
Organization:
Study Overview
Official Title:
Randomized, 1-Way Parallel, Bioequivalence Study of Bicalutamide 50 mg Tablets and Casodex® Administered as 1 x 50 mg Tablet in Healthy Subjects Under Fasting Conditions
Status:
COMPLETED
Status Verified Date:
2009-09
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 objective of this study is to compare the rate and extent of absorption of bicalutamide 50 mg tablets (test) versus Casodex® (reference) administered as 1 x 50 mg tablet under fasting conditions.
Detailed Description:
This will be a single center, bioequivalence, open-label, randomized, 1-way parallel study.
According to the BA/BE guidances, a parallel study is acceptable for drugs with a long half-life.
According to the BA/BE guidances, a parallel study is acceptable for drugs with a long half-life.
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?: