To Test Bioequivalence Between Two Tablet Formulations in the Treatment of Allergy

McNeil-PPC

Status and phase: Completed; Phase 1

Conditions: Allergy

Treatments: Drug: Cetirizine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01322282

CETALY1006

Details and patient eligibility

About

This study is designed to assess bioequivalence between two products used for treatment of allergy.

Full description

This study is designed to evaluate if a test formulation of cetirizine 10 mg orodispersible tablet (ODT) taken with and without water is bioequivalent to a marketed reference formulation of cetirizine 10 mg tablet (Benadryl One A Day, McNeil Products Ltd, UK) taken with water. This study will also evaluate the tolerability of test and reference formulations.

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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36 participants in 3 patient groups

ODT with Water

Experimental group

Description:

Experimental Cetirizine 10 mg Orodispersible Tablet (ODT) taken with 240 mL of water

Treatment:

Drug: Cetirizine

Drug: Cetirizine

ODT Without Water

Experimental group

Description:

Experimental Cetirizine 10 mg Orodispersible Tablet (ODT) taken without 240 mL of water

Treatment:

Drug: Cetirizine

Drug: Cetirizine

FCT with Water

Active Comparator group

Description:

Marketed Cetirizine 10 mg Film-Coated Tablet (FCT) taken with 240 mL of water

Treatment:

Drug: Cetirizine

Drug: Cetirizine