Bioavailability of Flucanazole

Candidiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04502277
• Other study ID #: Diflucan
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: September 1, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: July 2020
• Source: Sutphin Drugs
• Contact: Ajau Prakash, Ph.D.
• Phone: 7185260310
• Email: sutphinrx[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Candidiasis

Intervention

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

Locations

Country	Name	City	State
India	Lifein Multi-Specialty Hospital	Navsari	Gujarat
United States	Sutphin Drugs	Jamaica	New York

Sponsors (1)

Lead Sponsor	Collaborator
Sutphin Drugs

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours