COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu
Trial record 28 of 783 for:    Area Under Curve AND Bioavailability

Bioavailability Study of Fluconazole Tablets 200 mg Under Fasting Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01511770
Recruitment Status : Completed
First Posted : January 19, 2012
Last Update Posted : January 19, 2012
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

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 fasting conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: Fluconazole Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : August 2002
Actual Primary Completion Date : August 2002
Actual Study Completion Date : September 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Fluconazole

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01511770

Layout table for location information
MDS Pharma Services
Cohen street, saint-laurent, montreal (quebec), Canada, H4R 2N6
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Layout table for investigator information
Principal Investigator: Gaetano Morelli, MD MDS Pharma Services
Layout table for additonal information
Responsible Party: Dr. Reddy's Laboratories Limited Identifier: NCT01511770    
Other Study ID Numbers: AA01660
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: January 2012
Keywords provided by Dr. Reddy's Laboratories Limited:
Additional relevant MeSH terms:
Layout table for MeSH terms
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors