Bioavailability Study of Fluconazole Tablets 200 mg Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01511770
First received: January 13, 2012
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

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 fasting conditions.


Condition Intervention Phase
Healthy
Drug: Fluconazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Fasting Condition.

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Area Under Curve (AUC) [ Time Frame: pre dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5,4, 6, 9, 12, 24, 48 and 72 hours post-dose. ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: August 2002
Study Completion Date: September 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluconazole
Fluconazole Tablets 200 mg of Dr. Reddy's Laboratories limited.
Drug: Fluconazole
Fluconazole Tablets, 200 mg
Other Name: Dr. Reddy's Laboratories
Active Comparator: Diflucan
Diflucan 200 mg fluconazole tablets of Pfizer
Drug: Fluconazole
Fluconazole 200 mg tablets
Other Name: Diflucan (Pfizer)

Detailed Description:

Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 18 healthy adult male volunteers. A total of 17 subjects completed the clinical phase of the study. In each period, subjects were housed from the morning dosing until after the 72-hour blood draw. Single oral 200 mg doses were separated by a washout period of 21 days.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511770

Locations
Canada
MDS Pharma Services
Cohen street, saint-laurent, montreal (quebec), Canada, H4R 2N6
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Gaetano Morelli, MD MDS Pharma Services
  More Information

No publications provided

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01511770     History of Changes
Other Study ID Numbers: AA01660
Study First Received: January 13, 2012
Last Updated: January 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Fluconazole
Crossover

Additional relevant MeSH terms:
Fluconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014