Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules

NCT ID: NCT01948011

Last Updated: 2014-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2013-11-30

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.

Conditions

Healthy Male Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Racecadotril 10mg suspension

single oral dose

Group Type: EXPERIMENTAL

Racecadotril granules

Intervention Type: DRUG

Racecadotril granules at 60mg. Single oral dose.

Racecadotril 30mg suspension

single oral dose

Group Type: EXPERIMENTAL

Racecadotril granules

Intervention Type: DRUG

Racecadotril granules at 60mg. Single oral dose.

Racecadotril 60mg suspension

single oral dose

Group Type: EXPERIMENTAL

Racecadotril granules

Intervention Type: DRUG

Racecadotril granules at 60mg. Single oral dose.

Racecadotril 60mg granules

single oral dose

Group Type: ACTIVE_COMPARATOR

Racecadotril suspension

Intervention Type: DRUG

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

Interventions

Racecadotril suspension

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

Intervention Type: DRUG

Racecadotril granules

Racecadotril granules at 60mg. Single oral dose.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bioprojet

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yves Donazzolo, MD

Role: PRINCIPAL_INVESTIGATOR

Eurofins Optimed

Locations

Eurofins Optimed

Gières, , France

Countries

France

Other Identifiers

2013-002746-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P13-01 / BP0.52

Identifier Type: -

Identifier Source: org_study_id