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

NCT01322282 | Completed Phase 1

• 1 other identifier: CETALY1006
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Allergy

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration

  Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, measured in nanograms/milliliter (ng/mL)

  During 32 hours post-dose

• Bioavailability [AUC(0-t)]

  Bioavailability \[AUC(0-t)\] is a measure of how much of the drug reaches the person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The Area Under the Curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour \* nanograms (ng) per milliliter (mL).

  During 32 hours post-dose

• Bioavailability Extrapolated to Infinity [AUC (0-∞)]

  Bioavailability Extrapolated to Infinity \[AUC (0-∞)\] is a calculated measure of how much of the drug will ever reach the person's bloodstream for the body to use. AUC (0-∞) stands for the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (forever). It is obtained from calculating AUC (0-t) plus AUC (t-∞).

  32 hours post-dose

Secondary Outcomes (6)

• Time of Maximum Concentration

  During 32 hours post-dose

• Terminal Elimination Rate Constant

  During 32 hours post-dose

• Terminal Phase Plasma Half-Life

  During 32 hours post-dose

• Area under the Curve to the Tmax of the Reference Products

  During 32 hours post-dose

• Relative percentage of AUCT with respect to AUC∞ (AUCT/∞)

  During 32 hours post-dose

Study Arms (3)

ODT with Water

EXPERIMENTAL

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

Drug: Cetirizine

ODT Without Water

EXPERIMENTAL

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

Drug: Cetirizine

FCT with Water

ACTIVE COMPARATOR

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

Drug: Cetirizine

Interventions

Cetirizine DRUG

A single 10 mg dose of an experimental Cetirizine Orodispersible Tablet (ODT), with a 7-day washout period between visits

Also known as: Not yet marketed

ODT Without Water; ODT with Water

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McNeil AB: lead

Study Sites (1)

Algorithme Pharma Inc.

Mount Royal, Quebec, H3P 3P1, Canada

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Cetirizine

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Elisabeth Kruse, PhD

  McNeil AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 24, 2011
• Study Start: February 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

CA (1)