Bioavailability of Flucanazole

Early Phase 1

• Conditions: Candidiasis
• Interventions: Drug: Fluconazole Powder

• Registration Number: NCT04502277
• Lead Sponsor: Sutphin Drugs

Brief Summary

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

Detailed Description

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 Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-08-05
• Last Update Submitted: 2020-08-05
• Study First Posted: 2020-08-06
• Last Update Posted: 2020-08-06
• Study Start: 2020-09-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Flucanazole	Fluconazole Powder	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 to measure AUC at 0, 1 , 4 , 8, 12, 16 , 20 and 24 hours Under Fed Condition
Diflucan	Fluconazole Powder	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

Primary Outcome Measures

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

Trial Locations

Locations (2)

Lifein Multi-Specialty Hospital; 🇮🇳 Navsari, Gujarat, India

Sutphin Drugs; 🇺🇸 Jamaica, New York, United States