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

Allergy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01322282
• Other study ID #: CETALY1006
• Status: Completed
• Phase: Phase 1
• First received: March 23, 2011
• Last updated: July 6, 2012
• Start date: February 2011
• Est. completion date: March 2011

Study information

• Verified date: July 2012
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Allergy

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Canada	Algorithme Pharma Inc.	Mount-Royal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McNeil AB

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Bioavailability Extrapolated to Infinity [AUC (0-8)]	Bioavailability Extrapolated to Infinity [AUC (0-8)] is a calculated measure of how much of the drug will ever reach the person's bloodstream for the body to use. AUC (0-8) 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-8).	32 hours post-dose	No
Secondary	Time of Maximum Concentration	The time at which maximum concentration is reached (Tmax)	During 32 hours post-dose	No
Secondary	Terminal Elimination Rate Constant	The Terminal Elimination Rate Constant (Lamda z) is the time required to eliminate half the administered dose	During 32 hours post-dose	No
Secondary	Terminal Phase Plasma Half-Life	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.	During 32 hours post-dose	No
Secondary	Area under the Curve to the Tmax of the Reference Products	Area under the plasma concentration versus time curve to the time of the maximum concentration of the reference products (AUCReftmax)	During 32 hours post-dose	No
Secondary	Relative percentage of AUCT with respect to AUC8 (AUCT/8)	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.; AUC8 is the area under the plasma concentration versus time curve from start of drug administration until extrapolated infinite time.; AUCT/ AUC8 is an inversed measure of how large the extrapolated area under the curve is.	During 32 hours post-dose	No
Secondary	Mean Residence Time	The average amount of time a particle (e.g., a drug substance molecule) remains in a compartment or system.	During 32 hours post-dose	No