Bioavailability of Flucanazole

Status unconfirmed · Early Phase 1

Conditions studied: Candidiasis

In brief

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

Key facts

Study ID

NCT04502277

Run by

Sutphin Drugs

People needed

200

Starts

2020-09-01

Expected to finish

2021-01-31

Last updated by the study team

2020-08-06

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

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 30 days prior to first dose.
• Subjects who have been anormal diet during the 30 days prior to the first dosing.

Where it is running

• Sutphin Drugs — Jamaica, New York, United States
• Lifein Multi-Specialty Hospital — Navsari, Gujarat, India

Full record on ClinicalTrials.gov

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