Bioavailability of Flucanazole

Early Phase 1UnknownNCT04502277

Sutphin Drugs200 enrolled

Overview

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

The study is to be conducted as an open-label, randomized, single-dose, 2-way crossover, relative bio availability study performed on 200 healthy adult volunteers. A total 200 subjects will be assessed for AUC for 72 hours after administration of flucanazole suspension

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

200

Conditions

Candidiasis

Interventions

Fluconazole PowderDRUG

The Objective of This Study Was an Open-label, Randomized, 2-way Crossover to Compare the Single-dose Relative Bioavailability of Diflucan 40mgm/ml 35 ml Suspension and to measure AUC at 0, 1 , 4 , 8, 12, 16 , 20 and 24 hours Under Fed Condition

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Sutphin Drugs

Jamaica, New York, United States

Lifein Multi-Specialty Hospital

Navsari, Gujarat, India

Outcomes

Primary Outcomes

Bio availability

To measure the AUC at 0, 1 , 4 , 8, 12, 16 , 20 and 24 hours after a single dose administration of Under Fed Condition

Time frame: 24 hours

Central Contacts

Ajau Prakash, Ph.D.

CONTACT

7185260310 sutphinrx@gmail.com

Data from ClinicalTrials.gov

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