NCT04502277

Bioavailability of Flucanazole

Comparative,Randomized,Single-dose,2-way Crossover Bioavailability Study of 40mgm/ml 35 ml Suspension and Pfizer (Diflucan®) 40 mg/ml 35 ml Fluconazole Suspension of Participants Under Fed Condition

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Sutphin Drugs · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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

Conditions

• Candidiasis

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2020-09-01
• Primary completion: 2020-12-31
• Completion: 2021-01-31
• First posted: 2020-08-06
• Last updated: 2020-08-06

Locations

2 sites across 2 countries: United States, India

Regulatory

• FDA-regulated drug study