AllergyPhase 1NCT01322282
To Test Bioequivalence Between Two Tablet Formulations in the Treatment of Allergy
A Phase 1 study testing Cetirizine in people with Allergy, run by McNeil AB at 1 site in Canada.
Trial summary
This study is designed to assess bioequivalence between two products used for treatment of allergy. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy
- What is being tested?
- Cetirizine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2011to Mar 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
This study is designed to assess bioequivalence between two products used for treatment of allergy.
Read the 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.
- Conditions
- Allergy
- Being tested
- Cetirizine
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetirizineDrug
Also called Not yet marketed
A single 10 mg dose of an experimental Cetirizine Orodispersible Tablet (ODT), with a 7-day washout period between visits
CetirizineDrug
Also called Benadryl One A Day 10 mg Film-Coated Tablet
A single 10 mg dose of a marketed Cetirizine Film-Coated Tablet (FCT), with a 7-day washout period between visits
| Study group | Role | What they receive |
|---|---|---|
| ODT with Water | Experimental | Experimental Cetirizine 10 mg Orodispersible Tablet (ODT) taken with 240 mL of water Receives: Drug: Cetirizine |
| ODT Without Water | Experimental | Experimental Cetirizine 10 mg Orodispersible Tablet (ODT) taken without 240 mL of water Receives: Drug: Cetirizine |
| FCT with Water | Active comparator | Marketed Cetirizine 10 mg Film-Coated Tablet (FCT) taken with 240 mL of water Receives: Drug: Cetirizine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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-∞).
Measured: 32 hours post-dose
Secondary outcomes (6)
Time of Maximum Concentration
The time at which maximum concentration is reached (Tmax)
Measured: During 32 hours post-dose
Terminal Elimination Rate Constant
The Terminal Elimination Rate Constant (Lamda z) is the time required to eliminate half the administered dose
Measured: During 32 hours post-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.
Measured: During 32 hours post-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)
Measured: During 32 hours post-dose
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.
Measured: During 32 hours post-dose
Mean Residence Time
The average amount of time a particle (e.g., a drug substance molecule) remains in a compartment or system.
Measured: During 32 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabeth Kruse, PhD, Study director, McNeil AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322282
- Sponsor's protocol ID
- CETALY1006
- Status last verified
- Jul 2012
- First submitted
- 23 Mar 2011
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01322282
- Acronym / sponsor ID
- CETALY1006
- Conditions
- Allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 24 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ODT with Water | Experimental | Drug: CetirizineExperimental Cetirizine 10 mg Orodispersible Tablet (ODT) taken with 240 mL of water |
| ODT Without Water | Experimental | Drug: CetirizineExperimental Cetirizine 10 mg Orodispersible Tablet (ODT) taken without 240 mL of water |
| FCT with Water | Active comparator | Drug: CetirizineMarketed Cetirizine 10 mg Film-Coated Tablet (FCT) taken with 240 mL of water |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetirizineAlso: Not yet marketedA single 10 mg dose of an experimental Cetirizine Orodispersible Tablet (ODT), with a 7-day washout period between visits | Drug | ODT Without Water, ODT with Water |
| CetirizineAlso: Benadryl One A Day 10 mg Film-Coated TabletA single 10 mg dose of a marketed Cetirizine Film-Coated Tablet (FCT), with a 7-day washout period between visits | Drug | FCT with Water |
Primary outcome
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)
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).
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-∞).
6 secondary outcomes
Time of Maximum Concentration
Time frame: During 32 hours post-dose
Terminal Elimination Rate Constant
Time frame: During 32 hours post-dose
Terminal Phase Plasma Half-Life
Time frame: During 32 hours post-dose
Area under the Curve to the Tmax of the Reference Products
Time frame: During 32 hours post-dose
Relative percentage of AUCT with respect to AUC∞ (AUCT/∞)
Time frame: During 32 hours post-dose
Mean Residence Time
Time frame: During 32 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Kruse, PhD study director
McNeil AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cetirizine in people with Allergy, run by McNeil AB at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (time frame: During 32 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2012.