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Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules

NCT01948011 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2014-02-25

No results posted yet for this study

Summary

To investigate the Racecadotril pharmacokinetic linearity after single oral administration of 10, 30 and 60 mg as a suspension.

To evaluate the comparative bioavailability of the new Racecadotril formulation (suspension) versus the reference sachet formulation (granules)

Conditions

  • Healthy Male Volunteers

Interventions

DRUG

Racecadotril suspension

Racecadotril suspension at 10, 30 and 60mg. Single oral dose.

DRUG

Racecadotril granules

Racecadotril granules at 60mg. Single oral dose.

Sponsors & Collaborators

Principal Investigators

  • Yves Donazzolo, MD · Eurofins Optimed

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-11-30
Completion
2013-11-30

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 NCT01948011 on ClinicalTrials.gov