NCT03821480

Diflucan Bioequivalence Study For Transferring The Manufacture

AN OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER PIVOTAL BIOEQUIVALENCE STUDY OF FLUCONAZOLE CAPSULE 50 MG IN HEALTHY ADULT SUBJECTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is to assess the bioequivalence between fluconazole 50mg capsules from two different manufacturers. This is a open-label, randomized, single dose, 2-treatment, 2-period crossover study in healthy Korean male and female subjects aged 19-55, to assess the bioequivalence after taking study drugs.

Detailed description

Twenty-eight (28) healthy subjects will be enrolled into the study. Screening evaluation will occur within 28 days prior to the first dose of study medication. Subjects will be randomized to the following treatments: * Treatment A: Fluconazole capsule, 1 x 50 mg, Diflucan, West Ryde (REFERENCE) * Treatment B: Fluconazole capsule, 1 x 50 mg, Diflucan, Amboise (TEST)

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Test drug	Fluconazole capsule 50 mg Manufacturer: West Ryde
DRUG	Reference drug	Fluconazole capsule 50 mg Manufacturer: Amboise

Timeline

• Start date: 2019-01-28
• Primary completion: 2019-03-06
• Completion: 2019-03-06
• First posted: 2019-01-29
• Last updated: 2021-07-16

Locations

1 site across 1 country: South Korea