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Completed

NCT Number: NCT01322282

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

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

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Key information

Conditions

Allergy Hypersensitivity Immune System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Algorithme Pharma Inc.

Mount Royal, Quebec, H3P 3P1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cetirizine

Drug

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

Other names: Not yet marketed

Primary outcomes

  1. Maximum Observed Plasma Concentration

    Time frame: During 32 hours post-dose

    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)

  2. Bioavailability [AUC(0-t)]

    Time frame: During 32 hours post-dose

    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).

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

    Time frame: 32 hours post-dose

    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-∞).

Secondary outcomes

  1. Time of Maximum Concentration

    Time frame: During 32 hours post-dose

    The time at which maximum concentration is reached (Tmax)

  2. Terminal Elimination Rate Constant

    Time frame: During 32 hours post-dose

    The Terminal Elimination Rate Constant (Lamda z) is the time required to eliminate half the administered dose

  3. Terminal Phase Plasma Half-Life

    Time frame: During 32 hours post-dose

    Terminal phase plasma half-life (t ½) is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, rather than the time required to eliminate half the administered dose.

  4. Area under the Curve to the Tmax of the Reference Products

    Time frame: During 32 hours post-dose

    Area under the plasma concentration versus time curve to the time of the maximum concentration of the reference products (AUCReftmax)

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

    Time frame: During 32 hours post-dose

    AUCT is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration.

    AUC∞ is the area under the plasma concentration versus time curve from start of drug administration until extrapolated infinite time.

    AUCT/ AUC∞ is an inversed measure of how large the extrapolated area under the curve is.

  6. Mean Residence Time

    Time frame: During 32 hours post-dose

    The average amount of time a particle (e.g., a drug substance molecule) remains in a compartment or system.

Sponsors and collaborators

Lead sponsor

McNeil AB

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 24, 2011
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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