Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules

Phase 1

Completed

• Conditions: Healthy Male Volunteers
• Interventions: Drug: Racecadotril granules; Drug: Racecadotril suspension

• Registration Number: NCT01948011
• Lead Sponsor: Bioprojet

Brief 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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-11
• Study First Submitted QC: 2013-09-19
• Study First Posted: 2013-09-23
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-24
• Last Update Posted: 2014-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 53

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Racecadotril 10mg suspension	Racecadotril granules	single oral dose
Racecadotril 30mg suspension	Racecadotril granules	single oral dose
Racecadotril 60mg granules	Racecadotril suspension	single oral dose
Racecadotril 60mg suspension	Racecadotril granules	single oral dose

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Eurofins Optimed; 🇫🇷 Gières, France