NCT01948011

Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules

Study of the Racecadotril Linearity After Single Administrations of 10, 30 and 60 mg of a New Racecadotril Formulation (Suspension) by Oral Route and Evaluation of the Comparative Bioavailability of This New Formulation Versus the Sachet Formulation (Granules) After a 60 mg Single Oral Administration in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Bioprojet · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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)

Detailed description

This is a single center, open-label, single oral dose, 4-period cross-over study to assess the bioequivalence of a new formulation (suspension) in healthy male volunteers.

Conditions

• Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	Racecadotril suspension	Racecadotril suspension at 10, 30 and 60mg. Single oral dose.
DRUG	Racecadotril granules	Racecadotril granules at 60mg. Single oral dose.

Timeline

• Start date: 2013-09-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2013-09-23
• Last updated: 2014-02-25

Locations

1 site across 1 country: France