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
2 other identifiers
interventional
53
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2013
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 11, 2013
CompletedFirst Posted
Study publicly available on registry
September 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedFebruary 25, 2014
February 1, 2014
2 months
September 11, 2013
February 24, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (4)
Racecadotril 10mg suspension
EXPERIMENTALsingle oral dose
Racecadotril 30mg suspension
EXPERIMENTALsingle oral dose
Racecadotril 60mg suspension
EXPERIMENTALsingle oral dose
Racecadotril 60mg granules
ACTIVE COMPARATORsingle oral dose
Interventions
Racecadotril suspension at 10, 30 and 60mg. Single oral dose.
Racecadotril granules at 60mg. Single oral dose.
Eligibility Criteria
You may qualify if:
- Healthy male,
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bioprojetlead
Study Sites (1)
Eurofins Optimed
Gières, 38610, France
Study Officials
- PRINCIPAL INVESTIGATOR
Yves Donazzolo, MD
Eurofins Optimed
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2013
First Posted
September 23, 2013
Study Start
September 1, 2013
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
February 25, 2014
Record last verified: 2014-02