Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy Male Volunteers

Intervention / Treatment
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* Drug: Racecadotril suspension
* Drug: Racecadotril granules


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Racecadotril 10mg suspension<br>single oral dose | Drug: Racecadotril granules<br>* Racecadotril granules at 60mg. Single oral dose.<br>|
| Experimental: Racecadotril 30mg suspension<br>single oral dose | Drug: Racecadotril granules<br>* Racecadotril granules at 60mg. Single oral dose.<br>|
| Experimental: Racecadotril 60mg suspension<br>single oral dose | Drug: Racecadotril granules<br>* Racecadotril granules at 60mg. Single oral dose.<br>|
| Active Comparator: Racecadotril 60mg granules<br>single oral dose | Drug: Racecadotril suspension<br>* Racecadotril suspension at 10, 30 and 60mg. Single oral dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |