Study to Compare the Pharmacokinetics Profiles of Four Racecadotril Products
NCT ID: NCT01476683
Last Updated: 2012-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2011-12-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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FCT
A single 2 x100 mg dose of an experimental Racecadotril Film-coated tablet (FCT) administered orally with 240 ml of water, with a 7- day washout between visits.
Racecadotril
Film-coated tablet
RPB
A single 2 x100 mg dose of an experimental Racecadotril Powder Blend administered orally with 240 ml of water, with a 7- day washout between visits.
Racecadotril
Racecadotril Powder Blend
TFT
A single 2 x 100 mg dose of a marketed Tiorfast® capsule administered orally with 240 ml of water, with a 7-day washout between visits.
Racecadotril
Marketed Capsule
TFR
A single 175 mg dose of a marketed Tiorfanor® 175 mg FCT administered orally with 240 ml of water, with a 7-day washout between visits.
Racecadotril
Marketed Film-coated Tablet
Interventions
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Racecadotril
Film-coated tablet
Racecadotril
Racecadotril Powder Blend
Racecadotril
Marketed Capsule
Racecadotril
Marketed Film-coated Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Volunteers aged of at least 18 years but not older than 55 years
* Subjects will have a Body Mass Index (BMI) within protocol-specified parameters.
* Non- or ex-smokers; an ex-smoker being defined as someone who completely stopped smoking for at least 12 months before day 1 of this study.
* Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations Has signed and dated the informed consent document, indicating that the subject has been informed of all pertinent aspects of the study
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Exclusion Criteria
* Relationship to persons involved directly with the conduct of the study (i.e., principal investigator; sub-investigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson \& Johnson subsidiaries; and the families of each)
* Females who are pregnant or are lactating
* Females of childbearing potential or males with a female partner of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the entire duration of the study
* History of significant hypersensitivity to racecadotril or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
* Use of certain drugs/medications within protocol-specified timeframes
* Medical history or condition that may, per protocol or in the opinion of the investigator, adversely affect the safety of the study subject or compromise study results.
18 Years
55 Years
ALL
Yes
Sponsors
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McNeil AB
INDUSTRY
Responsible Party
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Principal Investigators
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Elisabeth Kruse, PhD
Role: STUDY_DIRECTOR
McNeil AB
Locations
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Algorithme Pharma Inc.
Mount Royal, Quebec, Canada
Countries
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Other Identifiers
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RACDIR1002
Identifier Type: -
Identifier Source: org_study_id