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Bioavailability of Flucanazole

Sponsored by Sutphin Drugs

About this trial

Last updated 6 years ago

Study ID

Diflucan

Status

Unknown

Type

Interventional

Phase

Early Phase 1

Placebo

No

Accepting

18 to 35 Years
All Sexes

Trial Timing

Ended 5 years ago

What is this trial about?

The Objective of This Study Was an Open-label, Randomized, 2-way Crossover to Compare the Single-dose Relative Bioavailability of Flucanazole 40mgm/ml 35 ml Suspension and Pfizer (Diflucan®) 40 mg/ml 35 ml Fluconazole Suspension Under Fed Condition

What are the Participation Requirements?

Inclusion Criteria Male and females between the ages of 18 and 35 years * Healthy Individual * Able to swallow 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 30 days prior to first dose. Subjects who have been anormal diet during the 30 days prior to the first dosing.