Who is sponsoring NCT01948011?

NCT01948011 is sponsored by Bioprojet.

What condition does NCT01948011 study?

NCT01948011 studies Healthy Male Volunteers.

What drugs are being tested in NCT01948011?

Interventions: Racecadotril suspension, Racecadotril granules.

What is the status of NCT01948011?

NCT01948011 is currently COMPLETED.

Last reviewed 2014-02-24 · How we verify

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

NCT01948011 Phase 1 COMPLETED

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)

Details

Lead sponsor	Bioprojet
Phase	Phase 1
Status	COMPLETED
Enrolment	53
Start date	2013-09
Completion	2013-11

Conditions

Healthy Male Volunteers

Interventions

Racecadotril suspension
Racecadotril granules

Primary outcomes

Bio-equivalence — Total study duration per subject should be 6 weeks.
Several blood sample will be collected at each period to investigate the racecadotril pharmacokinetic linearity and to evaluate the comparative bioavalibility. 4-period, cross over, single oral dose at each period.

Countries

France