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Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions

NCT01340157 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-03-31

No results posted yet for this study

Summary

The present study is designed to assess the impact of concomitant food intake on the relative bioavailability of a single oral fexinidazole tablet administration.

Conditions

  • PK in Healthy Volunteers

Interventions

DRUG

Fexinidazole

Single oral dose of 1200mg fexinidazole consisting of 2 tablets dosed at 600mg per tablet.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Lionel Hovsepian, MD · SGS Aster

  • Antoine Tarral, MD · Drugs for Neglected Diseases initiative

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • France

Study Locations

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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 NCT01340157 on ClinicalTrials.gov