Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-25 @ 4:12 PM
Study NCT ID:
NCT01133457
Status:
COMPLETED
Last Update Posted:
2010-05-28
First Post:
2010-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed Condition
Sponsor:
Dr. Reddy's Laboratories Limited
Organization:
Study Overview
Official Title:
Comparative,Randomized,Single-dose,2-way Crossover Bioavailability Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg and Merck & Co., Propecia in Healthy Adult Males Under Fed Condition.
Status:
COMPLETED
Status Verified Date:
2002-03
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 was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Merck \& Co. (Propecia®)
1 mg finasteride tablets under fed conditions following administration of a 3 mg dose.
1 mg finasteride tablets under fed conditions following administration of a 3 mg dose.
Detailed Description:
Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 24 healthy adult male volunteers and 2 alternates. A total of 24 subjects completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 36-hour blood draw. Single oral 3 mg doses were separated by a washout period of 7 days.
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?: