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

Primary Purpose

Allergy

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Cetirizine
Cetirizine
Sponsored by
McNeil AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Allergy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Algorithme Pharma Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

ODT with Water

ODT Without Water

FCT with Water

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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)
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).
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-∞).

Secondary Outcome Measures

Time of Maximum Concentration
The time at which maximum concentration is reached (Tmax)
Terminal Elimination Rate Constant
The Terminal Elimination Rate Constant (Lamda z) is the time required to eliminate half the administered dose
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.
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)
Relative percentage of AUCT with respect to AUC∞ (AUCT/∞)
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.
Mean Residence Time
The average amount of time a particle (e.g., a drug substance molecule) remains in a compartment or system.

Full Information

First Posted
March 23, 2011
Last Updated
July 6, 2012
Sponsor
McNeil AB
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1. Study Identification

Unique Protocol Identification Number
NCT01322282
Brief Title
To Test Bioequivalence Between Two Tablet Formulations in the Treatment of Allergy
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McNeil AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ODT with Water
Arm Type
Experimental
Arm Description
Experimental Cetirizine 10 mg Orodispersible Tablet (ODT) taken with 240 mL of water
Arm Title
ODT Without Water
Arm Type
Experimental
Arm Description
Experimental Cetirizine 10 mg Orodispersible Tablet (ODT) taken without 240 mL of water
Arm Title
FCT with Water
Arm Type
Active Comparator
Arm Description
Marketed Cetirizine 10 mg Film-Coated Tablet (FCT) taken with 240 mL of water
Intervention Type
Drug
Intervention Name(s)
Cetirizine
Other Intervention Name(s)
Not yet marketed
Intervention Description
A single 10 mg dose of an experimental Cetirizine Orodispersible Tablet (ODT), with a 7-day washout period between visits
Intervention Type
Drug
Intervention Name(s)
Cetirizine
Other Intervention Name(s)
Benadryl One A Day 10 mg Film-Coated Tablet
Intervention Description
A single 10 mg dose of a marketed Cetirizine Film-Coated Tablet (FCT), with a 7-day washout period between visits
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration
Description
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)
Time Frame
During 32 hours post-dose
Title
Bioavailability [AUC(0-t)]
Description
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).
Time Frame
During 32 hours post-dose
Title
Bioavailability Extrapolated to Infinity [AUC (0-∞)]
Description
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-∞).
Time Frame
32 hours post-dose
Secondary Outcome Measure Information:
Title
Time of Maximum Concentration
Description
The time at which maximum concentration is reached (Tmax)
Time Frame
During 32 hours post-dose
Title
Terminal Elimination Rate Constant
Description
The Terminal Elimination Rate Constant (Lamda z) is the time required to eliminate half the administered dose
Time Frame
During 32 hours post-dose
Title
Terminal Phase Plasma Half-Life
Description
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.
Time Frame
During 32 hours post-dose
Title
Area under the Curve to the Tmax of the Reference Products
Description
Area under the plasma concentration versus time curve to the time of the maximum concentration of the reference products (AUCReftmax)
Time Frame
During 32 hours post-dose
Title
Relative percentage of AUCT with respect to AUC∞ (AUCT/∞)
Description
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.
Time Frame
During 32 hours post-dose
Title
Mean Residence Time
Description
The average amount of time a particle (e.g., a drug substance molecule) remains in a compartment or system.
Time Frame
During 32 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Kruse, PhD
Organizational Affiliation
McNeil AB
Official's Role
Study Director
Facility Information:
Facility Name
Algorithme Pharma Inc.
City
Mount-Royal
State/Province
Quebec
ZIP/Postal Code
H3P 3P1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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