Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules

Healthy Male Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948011
• Other study ID #: P13-01 / BP0.52
• Secondary ID: 2013-002746-36
• Status: Completed
• Phase: Phase 1
• First received: September 11, 2013
• Last updated: February 24, 2014
• Start date: September 2013
• Est. completion date: November 2013

Study information

• Verified date: February 2014
• Source: Bioprojet
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy male,

• 18 to 45 years old,

• be certified as normal by a comprehensive clinical assessment (detailed medical history and a complete physical examination), arterial blood pressure (BP), heart rate (HR), an ECG and laboratory investigations (haematological, blood chemistry tests, urinalysis), the results of which are within the normal range and/ or judged by the investigator as clinically acceptable for healthy subjects,

• Body Mass Index (BMI) between 18 and 28 kg/m2.

Exclusion Criteria:

• History of cardiovascular, pulmonary gastro-intestinal, hepatic, renal, metabolic, haematological, neurological, psychiatric, systemic, or infectious disease.

• Any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.

• Subject has used any drug including OTC products two weeks before the scheduled administration of study drug, except paracetamol (maximum 1g/day).

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Male Volunteers

Intervention

Drug:
• Racecadotril suspension
Racecadotril suspension at 10, 30 and 60mg. Single oral dose.
• Racecadotril granules
Racecadotril granules at 60mg. Single oral dose.

Locations

Country	Name	City	State
France	Eurofins Optimed	Gières

Sponsors (1)

Lead Sponsor	Collaborator
Bioprojet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bio-equivalence	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.	Total study duration per subject should be 6 weeks.	No