AllergyPhase 1NCT03772158
Cetirizine Chewable Bioequivalence and Food Effect Study
A Phase 1 study testing Cetirizine 10mg and Cetirizine 10 mg in people with Allergy, run by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division at 1 site in Canada.
Trial summary
The purpose of this study is to determine and compare the amount of study drug that gets into your blood after the administration of each of the three formulations of cetirizine under different conditions. 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 10mg and Cetirizine 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 11 Dec 2018to 3 Feb 2019
- 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
- Healthy male or female subject between the ages of 18 and 55 years, inclusive. Health is defined as the absence of clinically relevant abnormalities as judged by the Investigator on the basis of a detailed medical history, physical examination, blood pressure, pulse rate measurements, 12-lead electrocardiogram (ECG), as well as clinical laboratory tests. The responsible Investigator may request additional investigations or analyses if necessary.
- Non- or ex-tobacco user, being defined as someone who completely stopped smoking or using any form of tobacco or nicotine-containing product for at least 6 months before screening visit of this study.
- For females: Postmenopausal state (i.e. at least 1 year without menses without an alternative medical condition prior to the first study drug administration) or premenopausal /perimenopausal state with an effective means of contraception (as defined in Section 10.5.5).
- For males: No pregnant or lactating spouse or partner at screening and willingness to utilize an acceptable form of birth control with spouse or any potential partner during the study.
- Body Mass Index (BMI) ≥ 18.5 and ≤ 30 kg/m2 with a total body weight >50 kg.
- A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
- Is able to comprehend the requirements of the study (based upon clinical site personnel's assessment) and is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified within the protocol.
Who cannot join
- Use of prescription or non-prescription medications within 5 half-lives before the first IP administration unless these are contraceptives or occasional use of other medications approved by the Investigator.
- Use of any vitamins, dietary and herbal supplements within seven days before first dose of study drug.
- History of any allergy or hypersensitivity (e.g. skin reaction, asthma, angioedema) to cetirizine or any excipients of the formulations.
- If female: is pregnant, has a positive pregnancy test at screening or prior to the first study drug administration, or is planning to become pregnant during the duration of the study, and/or is breast-feeding.
- Has a history of gastrointestinal surgery other than appendectomy.
- Has hypertension, fluid retention, or heart disease either by history or by the medically qualified Investigator's medical judgment.
Show all 21Show fewer
- Currently suffering from asthma or has a medically significant history of asthma in the opinion of the investigator.
- Has clinically significant renal or hepatic impairment; according to the medically qualified Investigator discretion.
- Was treated with an investigational product within 28 days or within a period less than 5 times the drug's half-life, whichever is longer, preceding the first dose of study drug.
- Preplanned surgical procedures during the study period as this may interfere with the conduct of the study.
- History of alcoholism or substance abuse, as judged by the Investigator, within the past 6 months preceding this study.
- Consumed alcohol beverage(s) within 48 hours preceding the first dose of study drug.
- History of rare hereditary problems of galactose and/or lactose intolerance, lactase deficiency or glucose-galactose malabsorption.
- Any history of tuberculosis.
- Donation or loss of blood within 28 days prior to the first treatment visit if the estimated lost blood volume equaled or exceeded 50 mL.
- Donation or loss of blood within 56 days prior to the first treatment visit if the estimated lost blood volume equaled or exceeded 500 mL.
- Has any acute or chronic medical or psychiatric condition(s) that may increase the risk associated with study participation or IP administration or may interfere with the interpretation of study results and, in the judgment of the medically qualified Investigator, would make the subject inappropriate for entry into this study.
- Relationship to persons involved directly in 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 family of each).
- Has any clinically important abnormal value for serum chemistry, hematology, or urinalysis at screening. Laboratory values will generally be within the normal ranges, although minor deviations in tests (except those explicitly specified in the inclusion criteria) that are not considered clinically important by the Investigator are acceptable.
- Has a positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (anti-HCV).
- Has a positive test for alcohol or drugs of abuse at screening or prior to the first study drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-Dose, Four-Treatment Crossover Bioequivalence and Food Effect Study of Test Formulation of Cetirizine 10mg Chewable Tablets Versus Two Marketed Cetirizine 10mg Immediate Release Tablets.
The purpose of this study is to determine and compare the amount of study drug that gets into your blood after the administration of each of the three formulations of cetirizine under different conditions. Another objective of this study is to evaluate the effect of food on the amount of study drug that gets into your blood after the administration of the investigational formulation. Other objectives of this study are to determine the sensory experience and ease of swallowing the investigational formulation, as well as to determine the safety of test and reference formulations of cetirizine.
Read the detailed description
The purpose of this study is to establish bioequivalence of a cetirizine 10 mg chewable tablet manufactured at Johnson \& Johnson Consumer Inc. (McNeil LLC) with two commercially marketed cetirizine 10 mg immediate release (IR) tablets (ZYRTEC®, US reference) and (Australian/EU reference), establish bioequivalence between the two commercial products (ZYRTEC®, US reference and REACTINE®, Australian/EU reference), and to evaluate the effect of food on bioavailability of the cetirizine 10 mg chewable tablet compared to the bioavailability of cetirizine 10 mg chewable tablet administrated with water only. In addition, subject's sensory experience and ease of swallowing of the test product will be assessed.
- Conditions
- Allergy
- Being tested
- Cetirizine 10mg, Cetirizine 10 mg
- Keywords
- Bioequivalence study, Healthy volunteers, Cetirizine, Tablet
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetirizine 10mgDrug
Also called Test product
Chewable tablet
Cetirizine 10 mgDrug
Also called ZYRTEC 10 mg
Immediate Release Tablet
Cetirizine 10 mgDrug
Also called REACTINE 10 mg
Immediate Release Tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Single dose of 10 mg cetirizine as a chewable tablet, administered orally after a 10-hour overnight fast and followed with 240 mL ambient water. Subjects will be instructed to chew the tablet completely before swallowing. Receives: Drug: Cetirizine 10mg |
| Treatment B | Experimental | Single dose of 10 mg cetirizine as a chewable tablet, administered orally after a 10-hour overnight fast without water. Subjects will be instructed to chew the tablet completely before swallowing. Receives: Drug: Cetirizine 10mg |
| Treatment C | Experimental | Single dose of 10 mg cetirizine as a chewable tablet, administered orally after a 10-hour overnight fast and 30 minutes after the start of the standard high-fat breakfast and followed with 240 mL ambient water. Subjects will be instructed to chew the tablet completely before swallowing. Receives: Drug: Cetirizine 10mg |
| Treatment D | Active comparator | Single dose of currently marketed US 10 mg cetirizine as immediate release tablet (ZYRTEC®), administered orally after a 10-hour overnight fast and followed with 240 mL ambient water. Receives: Drug: Cetirizine 10 mg |
| Treatment E | Active comparator | Single dose of currently marketed EU/Australian 10 mg cetirizine film coated tablet (REACTINE®) administered orally after a 10-hour overnight fast and followed with 240 mL ambient water. Receives: Drug: Cetirizine 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum observed plasma concentration (Cmax) of cetirizine
The maximum observed plasma concentration.
Measured: At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.
The area under the plasma concentration versus time curves to the last measurable concentration (AUCt)
Area under the plasma concentration versus time curve from start of drug administration until last measurable concentration.
Measured: At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.
Secondary outcomes (7)
Area under the plasma concentration versus time curve extrapolated to infinity
Area under the plasma concentration-time curve extrapolated to infinity.
Measured: At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.
The time point at which the maximum concentration of cetirizine is observed (Tmax).
The time point at which the maximum concentration of cetirizine occurs.
Measured: At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.
The terminal elimination half-life (T1/2) of cetirizine in plasma
The time it takes for the cetirizine plasma concentration to fall to half of its original value.
Measured: At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.
The terminal elimination rate constant (lambda z) for cetirizine in plasma.
The rate at which the drug is removed from the body system.
Measured: At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.
To assess subject's sensory experience and ease of swallowing of the test product
A questionaire with 5 product sensory questions for study subjects to answer.
Measured: Assessed one minute after dosing, and preferably completed within 15 minutes of dosing for treatments A, B and C
Number of patients with adverse events.
An adverse event is any untoward medical occurrence in a subject after they have signed an informed consent for a trial involving an investigational product.
Measured: Approximately 3 months. From signed informed consent until 30 days after last treatment administration.
The extrapolated part of the area under the plasma concentration versus time curve of cetirizine
The area under the plasma concentration versus time curve from 12 hours after start of drug administration until 48 hours after start of drug administration.
Measured: Extrapolated from 12 hours after start of drug administration until 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start11 Dec 2018
- Primary completion3 Feb 2019
- Study completion3 Feb 2019
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, single-dose, four-treatment crossover bioequivalence and food effect study of Cetirizine Chewable Tablets versus ZYRTEC® Immediate Release (IR) Tablets (US reference) and REACTINE® IR Tablets (EU and Australian marketed reference product). The study will be conducted in two parts. Part 1 of the study will have a randomized, four way crossover study design in which 40 healthy subjects, ages 18 to 55 years, will be randomized to four sequences of Treatments A, B, D and E over consecutive periods. No less than approximately 40% of either gender will be represented in the study population. Part 2 of the study will assess a potential food effect in which all subjects will be administered Treatment C in the fifth period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Sicard, MD, Principal investigator, Algorithme Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772158
- Sponsor's protocol ID
- CCSURA000499
- Status last verified
- Nov 2021
- First submitted
- 10 Dec 2018
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Dose, Four-Treatment Crossover Bioequivalence and Food Effect Study of Test Formulation of Cetirizine 10mg Chewable Tablets Versus Two Marketed Cetirizine 10mg Immediate Release Tablets.
- ClinicalTrials.gov ID
- NCT03772158
- Acronym / sponsor ID
- CCSURA000499
- Conditions
- Allergy
- Keywords
- Bioequivalence study, Healthy volunteers, Cetirizine, Tablet
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 3 Feb 2019 (actual)
- Study completion
- 3 Feb 2019 (actual)
- First posted
- 11 Dec 2018 (actual)
- 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.
The purpose of this study is to determine and compare the amount of study drug that gets into your blood after the administration of each of the three formulations of cetirizine under different conditions. Another objective of this study is to evaluate the effect of food on the amount of study drug that gets into your blood after the administration of the investigational formulation. Other objectives of this study are to determine the sensory experience and ease of swallowing the investigational formulation, as well as to determine the safety of test and reference formulations of cetirizine.
Detailed description
The purpose of this study is to establish bioequivalence of a cetirizine 10 mg chewable tablet manufactured at Johnson \& Johnson Consumer Inc. (McNeil LLC) with two commercially marketed cetirizine 10 mg immediate release (IR) tablets (ZYRTEC®, US reference) and (Australian/EU reference), establish bioequivalence between the two commercial products (ZYRTEC®, US reference and REACTINE®, Australian/EU reference), and to evaluate the effect of food on bioavailability of the cetirizine 10 mg chewable tablet compared to the bioavailability of cetirizine 10 mg chewable tablet administrated with water only. In addition, subject's sensory experience and ease of swallowing of the test product will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- This is a randomized, single-dose, four-treatment crossover bioequivalence and food effect study of Cetirizine Chewable Tablets versus ZYRTEC® Immediate Release (IR) Tablets (US reference) and REACTINE® IR Tablets (EU and Australian marketed reference product). The study will be conducted in two parts. Part 1 of the study will have a randomized, four way crossover study design in which 40 healthy subjects, ages 18 to 55 years, will be randomized to four sequences of Treatments A, B, D and E over consecutive periods. No less than approximately 40% of either gender will be represented in the study population. Part 2 of the study will assess a potential food effect in which all subjects will be administered Treatment C in the fifth period.
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Cetirizine 10mgSingle dose of 10 mg cetirizine as a chewable tablet, administered orally after a 10-hour overnight fast and followed with 240 mL ambient water. Subjects will be instructed to chew the tablet completely before swallowing. |
| Treatment B | Experimental | Drug: Cetirizine 10mgSingle dose of 10 mg cetirizine as a chewable tablet, administered orally after a 10-hour overnight fast without water. Subjects will be instructed to chew the tablet completely before swallowing. |
| Treatment C | Experimental | Drug: Cetirizine 10mgSingle dose of 10 mg cetirizine as a chewable tablet, administered orally after a 10-hour overnight fast and 30 minutes after the start of the standard high-fat breakfast and followed with 240 mL ambient water. Subjects will be instructed to chew the tablet completely before swallowing. |
| Treatment D | Active comparator | Drug: Cetirizine 10 mgSingle dose of currently marketed US 10 mg cetirizine as immediate release tablet (ZYRTEC®), administered orally after a 10-hour overnight fast and followed with 240 mL ambient water. |
| Treatment E | Active comparator | Drug: Cetirizine 10 mgSingle dose of currently marketed EU/Australian 10 mg cetirizine film coated tablet (REACTINE®) administered orally after a 10-hour overnight fast and followed with 240 mL ambient water. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male or female subject between the ages of 18 and 55 years, inclusive. Health is defined as the absence of clinically relevant abnormalities as judged by the Investigator on the basis of a detailed medical history, physical examination, blood pressure, pulse rate measurements, 12-lead electrocardiogram (ECG), as well as clinical laboratory tests. The responsible Investigator may request additional investigations or analyses if necessary.
- Non- or ex-tobacco user, being defined as someone who completely stopped smoking or using any form of tobacco or nicotine-containing product for at least 6 months before screening visit of this study.
- For females: Postmenopausal state (i.e. at least 1 year without menses without an alternative medical condition prior to the first study drug administration) or premenopausal /perimenopausal state with an effective means of contraception (as defined in Section 10.5.5).
- For males: No pregnant or lactating spouse or partner at screening and willingness to utilize an acceptable form of birth control with spouse or any potential partner during the study.
- Body Mass Index (BMI) ≥ 18.5 and ≤ 30 kg/m2 with a total body weight >50 kg.
Key exclusion criteria (21 listed)
- Use of prescription or non-prescription medications within 5 half-lives before the first IP administration unless these are contraceptives or occasional use of other medications approved by the Investigator.
- Use of any vitamins, dietary and herbal supplements within seven days before first dose of study drug.
- History of any allergy or hypersensitivity (e.g. skin reaction, asthma, angioedema) to cetirizine or any excipients of the formulations.
- If female: is pregnant, has a positive pregnancy test at screening or prior to the first study drug administration, or is planning to become pregnant during the duration of the study, and/or is breast-feeding.
- Has a history of gastrointestinal surgery other than appendectomy.
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 |
|---|---|---|
| Cetirizine 10mgAlso: Test productChewable tablet | Drug | Treatment A, Treatment B, Treatment C |
| Cetirizine 10 mgAlso: ZYRTEC 10 mgImmediate Release Tablet | Drug | Treatment D |
| Cetirizine 10 mgAlso: REACTINE 10 mgImmediate Release Tablet | Drug | Treatment E |
Primary outcome
The maximum observed plasma concentration (Cmax) of cetirizine
Time frame: At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.
The maximum observed plasma concentration.
The area under the plasma concentration versus time curves to the last measurable concentration (AUCt)
Time frame: At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.
Area under the plasma concentration versus time curve from start of drug administration until last measurable concentration.
7 secondary outcomes
Area under the plasma concentration versus time curve extrapolated to infinity
Time frame: At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.
The time point at which the maximum concentration of cetirizine is observed (Tmax).
Time frame: At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.
The terminal elimination half-life (T1/2) of cetirizine in plasma
Time frame: At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.
The terminal elimination rate constant (lambda z) for cetirizine in plasma.
Time frame: At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.
To assess subject's sensory experience and ease of swallowing of the test product
Time frame: Assessed one minute after dosing, and preferably completed within 15 minutes of dosing for treatments A, B and C
Number of patients with adverse events.
Time frame: Approximately 3 months. From signed informed consent until 30 days after last treatment administration.
The extrapolated part of the area under the plasma concentration versus time curve of cetirizine
Time frame: Extrapolated from 12 hours after start of drug administration until 48 hours
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 1 Dec 2021.
- CSR synopsis for Bioequivalence Study.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Eric Sicard, MD principal investigator
Algorithme Pharma Inc
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 10mg and Cetirizine 10 mg in people with Allergy, run by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 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 7 inclusion and 21 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 1 Dec 2021. 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?
The maximum observed plasma concentration (Cmax) of cetirizine (time frame: At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.). The study lists 2 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 1 Dec 2021.