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A Study to Assess Bioequivalence of Fezolinetant Formulations in Healthy Female Participants

NCT04277624 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-10-18

No results posted yet for this study

Summary

The purpose of this study is to assess the bioequivalence of a single dose of fezolinetant test formulation compared to a single dose of fezolinetant reference formulation under fasting conditions. This study will also evaluate the safety and tolerability of a single dose of fezolinetant test formulation and a single dose of fezolinetant reference formulation.

Conditions

  • Healthy Volunteers

Interventions

DRUG

fezolinetant - test formulation

Administered orally

DRUG

fezolinetant - reference formulation

Administered orally

Sponsors & Collaborators

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Executive Medical Director · Astellas Pharma Global Development, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-20
Primary Completion
2021-02-21
Completion
2021-02-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04277624 on ClinicalTrials.gov