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

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

Study Overview

• Status: Unknown
• Conditions: Candidiasis
• Intervention / Treatment: Drug: Fluconazole Powder

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Navsari, Gujarat, India, 396421
      • Lifein Multi-Specialty Hospital
• United States
  • New York
    • Jamaica, New York, United States, 11435
      • Sutphin Drugs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Flucanazole; 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	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
ACTIVE_COMPARATOR: Diflucan; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sutphin Drugs

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): January 31, 2021

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (ACTUAL): August 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2020
• Last Update Submitted That Met QC Criteria: August 5, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Candidiasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Fluconazole
• Other Study ID Numbers: Diflucan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes