Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01948011

Enrollment

Registered

2013-09-23

Start date

2013-09-30

Completion date

2013-11-30

Last updated

2014-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Male Volunteers

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.

Interventions

DRUGRacecadotril suspension

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

DRUGRacecadotril granules

Racecadotril granules at 60mg. Single oral dose.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026