Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-28 @ 5:10 PM
Study NCT ID:
NCT01511757
Status:
COMPLETED
Last Update Posted:
2012-01-19
First Post:
2012-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability Study of Fluconazole Tablets 200 mg Under Fed Conditions
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 Fluconazole Tablets 200 mg and PFIZER (DIFLUCAN) 200 MG in Healthy Males Under Fed Condition.
Status:
COMPLETED
Status Verified Date:
2012-01
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 an open-label, randomized, 2-way crossover to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Pfizer (Diflucan®) 200 mg fluconazole tablets under fed conditions.
Detailed Description:
Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 16 healthy adult male volunteers. A total 15 subjects completed the clinical phase of the study. In each period, subjects were housed from the mornings dosing until after the 72-hour blood draw. Single oral 200 mg doses were separated by a washout period of 21 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?: