Healthy Male VolunteersPhase 1NCT01948011
Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules
A Phase 1 study testing Racecadotril suspension and Racecadotril granules in people with Healthy Male Volunteers, run by Bioprojet at 1 site in France.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- Racecadotril suspension and Racecadotril granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Nov 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
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)
Read the 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
- Being tested
- Racecadotril suspension, Racecadotril granules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Racecadotril suspensionDrug
Racecadotril suspension at 10, 30 and 60mg. Single oral dose.
Racecadotril granulesDrug
Racecadotril granules at 60mg. Single oral dose.
| Study group | Role | What they receive |
|---|---|---|
| Racecadotril 10mg suspension | Experimental | single oral dose Receives: Drug: Racecadotril granules |
| Racecadotril 30mg suspension | Experimental | single oral dose Receives: Drug: Racecadotril granules |
| Racecadotril 60mg suspension | Experimental | single oral dose Receives: Drug: Racecadotril granules |
| Racecadotril 60mg granules | Active comparator | single oral dose Receives: Drug: Racecadotril suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Total study duration per subject should be 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioprojet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves Donazzolo, MD, Principal investigator, Eurofins Optimed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948011
- Sponsor's protocol ID
- P13-01 / BP0.52
- Other IDs
- 2013-002746-36
- Status last verified
- Feb 2014
- First submitted
- 11 Sep 2013
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01948011
- Acronym / sponsor ID
- P13-01 / BP0.52
- Conditions
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- BioprojetUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 23 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Racecadotril 10mg suspension | Experimental | Drug: Racecadotril granulessingle oral dose |
| Racecadotril 30mg suspension | Experimental | Drug: Racecadotril granulessingle oral dose |
| Racecadotril 60mg suspension | Experimental | Drug: Racecadotril granulessingle oral dose |
| Racecadotril 60mg granules | Active comparator | Drug: Racecadotril suspensionsingle oral dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Racecadotril suspensionRacecadotril suspension at 10, 30 and 60mg. Single oral dose. | Drug | Racecadotril 60mg granules |
| Racecadotril granulesRacecadotril granules at 60mg. Single oral dose. | Drug | Racecadotril 10mg suspension, Racecadotril 30mg suspension, Racecadotril 60mg suspension |
Primary outcome
Bio-equivalence
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
Related trials for Healthy Male Volunteers
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Urinary Vitamin C Loss in Diabetic Subjects
Diabetes
RecruitingPhase 1/2
Vasopressin and Pain Perception in the Brain
Acute Pain
RecruitingPhase 1/2
Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Adults With and Without Androgenetic Alopecia
Androgenetic Alopecia (AGA), Healthy Volunteers - Male and Female
Not yet recruitingPhase 1
The Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants
Health Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Donazzolo, MD principal investigator
Eurofins Optimed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Racecadotril suspension and Racecadotril granules in people with Healthy Male Volunteers, run by Bioprojet at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bio-equivalence (time frame: Total study duration per subject should be 6 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2014.