To Test Bioequivalence Between Two Tablet Formulations in the Treatment of Allergy
NCT ID: NCT01322282
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
36 participants
INTERVENTIONAL
2011-02-28
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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ODT with Water
Experimental Cetirizine 10 mg Orodispersible Tablet (ODT) taken with 240 mL of water
Cetirizine
A single 10 mg dose of an experimental Cetirizine Orodispersible Tablet (ODT), with a 7-day washout period between visits
ODT Without Water
Experimental Cetirizine 10 mg Orodispersible Tablet (ODT) taken without 240 mL of water
Cetirizine
A single 10 mg dose of an experimental Cetirizine Orodispersible Tablet (ODT), with a 7-day washout period between visits
FCT with Water
Marketed Cetirizine 10 mg Film-Coated Tablet (FCT) taken with 240 mL of water
Cetirizine
A single 10 mg dose of a marketed Cetirizine Film-Coated Tablet (FCT), with a 7-day washout period between visits
Interventions
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Cetirizine
A single 10 mg dose of an experimental Cetirizine Orodispersible Tablet (ODT), with a 7-day washout period between visits
Cetirizine
A single 10 mg dose of a marketed Cetirizine Film-Coated Tablet (FCT), with a 7-day washout period between visits
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) greater than or equal to 18.50 and below 30.00 kg/m2
* 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 (hematology, biochemistry, ECG and urinalysis)
* 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
* Seated blood pressure below 90/60 mmHg or higher than 140/90 mmHg at screening
* 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)
* Presence of any tongue piercings
* Presence of braces
* 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
* Females who are pregnant according to a positive serum pregnancy test
* Any medical history or condition, or use of any drug or medication, that the investigator determines could compromise subject safety or the evaluation of 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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CETALY1006
Identifier Type: -
Identifier Source: org_study_id