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Bioequivalence (BE) Study Comparing Fluconazole 150mg Capsule Manufactured in China and in France

NCT03621072 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-07-16

No results posted yet for this study

Summary

China Food and Drug Administration (CFDA) initiated a generic consistency evaluation program to evaluate the quality and efficacy of the products manufactured in China in 2016. This is a bioequivalence study to support the program and to demonstrate the bioequivalence between the 150 mg fluconazole capsule manufactured at Pfizer Dalian, China (the localized originator, Test) and the 150 mg fluconazole capsule manufactured at Pfizer Fareva, Amboise, France (the originator, Reference) in healthy Chinese subjects under fasted and fed conditions. This open-lable, randomized, single-dose 2-way crossover study will enroll approximately 18 subjects for each condition. The primary endpoints are fluconazole area under the plasma concentration-time curve from time zero to 72 hours post-dose (AUC72) and Cmax.

Conditions

  • Bioequivalence

Interventions

DRUG

Fluconazole 150mg Capsule Originator

150mg fluconazole capsule (originator) manufactured at Pfizer Fareva, Amboise, France

DRUG

Fluconazole 150mg Capsule Localized Originator

150mg Fluconazole capsule (localized originator) manufactured at Pfizer, Dalian, China

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-03
Primary Completion
2019-07-20
Completion
2019-07-20
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03621072 on ClinicalTrials.gov