Back to resultsBioavailability Study of Fluconazole Tablets 200 mg Under Fed Conditions
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Fluconazole
Fluconazole
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring Bioequivalence, Fluconazole, Crossover
Eligibility Criteria
Inclusion Criteria:
Exclusion Criteria:
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:
- 500 mL of blood in 14 days, or
- 500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator),
- 1000 mL of blood in 90 days,
- 1250 mL of blood in 120 days,
- 1500 mL of blood in 180 days,
- 2000 mL of blood in 270 days,
- 2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days prior to the first dosing.
Sites / Locations
- MDS Pharma Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fluconazole
Diflucan
Arm Description
Fluconazole Tablets 200 mg of Dr. Reddy's Laboratories limited.
Diflucan 200 mg fluconazole tablets of Pfizer
Outcomes
Primary Outcome Measures
Area Under Curve (AUC)
Secondary Outcome Measures
Full Information
NCT ID
NCT01511757
First Posted
January 13, 2012
Last Updated
January 18, 2012
Sponsor
Dr. Reddy's Laboratories Limited
1. Study Identification
Unique Protocol Identification Number
NCT01511757
Brief Title
Bioavailability Study of Fluconazole Tablets 200 mg Under Fed Conditions
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
June 2002 (Actual)
Study Completion Date
July 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Reddy's Laboratories Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Bioequivalence, Fluconazole, Crossover
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluconazole
Arm Type
Experimental
Arm Description
Fluconazole Tablets 200 mg of Dr. Reddy's Laboratories limited.
Arm Title
Diflucan
Arm Type
Active Comparator
Arm Description
Diflucan 200 mg fluconazole tablets of Pfizer
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Other Intervention Name(s)
Dr. Reddy's Laboratories
Intervention Description
Fluconazole Tablets, 200 mg
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Other Intervention Name(s)
Diflucan (Pfizer)
Intervention Description
fluconazole 200 mg
Primary Outcome Measure Information:
Title
Area Under Curve (AUC)
Time Frame
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.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Exclusion Criteria:
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:
500 mL of blood in 14 days, or
500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator),
1000 mL of blood in 90 days,
1250 mL of blood in 120 days,
1500 mL of blood in 180 days,
2000 mL of blood in 270 days,
2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days prior to the first dosing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Morelli, MD
Organizational Affiliation
MDS Pharma Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
MDS Pharma Services
City
Cohen street, saint-laurent, montreal (quebec)
ZIP/Postal Code
H4R 2N6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Bioavailability Study of Fluconazole Tablets 200 mg Under Fed Conditions
We'll reach out to this number within 24 hrs