Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules

Bioprojet

Status and phase: Completed; Phase 1

Conditions: Healthy Male Volunteers

Treatments: Drug: Racecadotril suspension; Drug: Racecadotril granules

Study type: Interventional

Funder types: Other

Identifiers

NCT01948011

P13-01 / BP0.52

2013-002746-36 (EudraCT Number)

Details and patient eligibility

About

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)

Full 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.

Enrollment: 53 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

53 participants in 4 patient groups

Racecadotril 10mg suspension

Experimental group

Description:

single oral dose

Treatment:

Drug: Racecadotril granules

Racecadotril 30mg suspension

Experimental group

Description:

single oral dose

Treatment:

Drug: Racecadotril granules

Racecadotril 60mg suspension

Experimental group

Description:

single oral dose

Treatment:

Drug: Racecadotril granules

Racecadotril 60mg granules

Active Comparator group

Description:

single oral dose

Treatment:

Drug: Racecadotril suspension