Bioavailability Study of Fluconazole Tablets 200 mg Under Fed Conditions
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.
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Jun 2002
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
January 13, 2012
CompletedFirst Posted
Study publicly available on registry
January 19, 2012
CompletedJanuary 19, 2012
January 1, 2012
Same day
January 13, 2012
January 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area Under Curve (AUC)
pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 9, 12, 24, 48 and 72 hours post-dose.
Study Arms (2)
Fluconazole
EXPERIMENTALFluconazole Tablets 200 mg of Dr. Reddy's Laboratories limited.
Diflucan
ACTIVE COMPARATORDiflucan 200 mg fluconazole tablets of Pfizer
Interventions
Eligibility Criteria
You may not qualify if:
- History or presence of significant:
- cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
- In addition, history or presence of:
- alcoholism or drug abuse within the past year;
- hypersensitivity or idiosyncratic reaction to fluconazole or other azoles. Subjects who have used any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days prior to first dose.
- Subjects who have used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 28 days prior to first dose.
- Subjects who have been on an abnormal diet (for whatever reason) during the 28 days prior to the first dosing.
- Subjects who, through completion of the study, would have donated in excess of:
- mL of blood in 14 days, or
- mL of blood in 14 days (unless approved by the Principal Investigator),
- mL of blood in 90 days,
- mL of blood in 120 days,
- mL of blood in 180 days,
- mL of blood in 270 days,
- mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days prior to the first dosing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MDS Pharma Services
Cohen Street, Saint-laurent, Montreal (quebec), H4R 2N6, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gaetano Morelli, MD
MDS Pharma Services
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2012
First Posted
January 19, 2012
Study Start
June 1, 2002
Primary Completion
June 1, 2002
Study Completion
July 1, 2002
Last Updated
January 19, 2012
Record last verified: 2012-01