Status:
UNKNOWN
Bioavailability of Flucanazole
Lead Sponsor:
Sutphin Drugs
Conditions:
Candidiasis
Eligibility:
All Genders
18-35 years
Phase:
EARLY_PHASE1
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 ...
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 assesse...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04502277
Start Date
September 1 2020
End Date
January 31 2021
Last Update
August 6 2020
Active Locations (2)
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1
Sutphin Drugs
Jamaica, New York, United States, 11435
2
Lifein Multi-Specialty Hospital
Navsari, Gujarat, India, 396421