This study is designed to assess bioequivalence between two products used for treatment of
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Full eligibility criteria for NCT01322282
Ages eligible for Study
18 Years to 55 Years
Genders eligible for Study
Accepts Healthy Volunteers
Male or female subjects
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
Seated pulse rate below 45 bpm or higher than 90 bpm at screening
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.
All locations for NCT01322282
Algorithme Pharma Inc.
Mount-Royal, Quebec, Canada, H3P 3P1
View full eligibility
Tris trial is registered with FDA with number: NCT01322282. The sponsor of the trial is McNeil AB and it is looking for 36 volunteers for the current phase.
Official trial title: A Randomized, Open-Label, Single-Dose, Three-Period Crossover Bioequivalence Study to Compare an Orodispersible Tablet (ODT) Formulation of Cetirizine HCl 10 mg Taken With and Without Water Compared With a Standard Marketed 10 mg Tablet Taken With Water
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