AllergyPhase 1NCT04071821

Relative Bioavailability Study to Evaluate Cetirizine HCl Gummy 10 mg and Cetirizine HCl Oral Tablets 10 mg

A Phase 1 study testing cetirizine HCl Gummy and Zyrtec tablet 10mg in people with Allergy, run by Seattle Gummy Company.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

A Randomized, Open-Label, Single-Dose, Five-Period Crossover, Relative Bioavailability Study to Evaluate Cetirizine HCl Gummy 10 mg and Cetirizine HCl Oral Tablets 10 mg Administered in Healthy Adult Male and Female Subjects 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 HCl Gummy and Zyrtec tablet 10mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: 1 May 2025to 30 Sep 2025
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

Are capable of giving informed consent and complying with study procedures;
Male or female, 18 to 55 years of age, inclusive, at date of consent;
Body mass index (BMI) ≥ 18.0 to ≤ 32.0 kg/m2 and total body weight > 50 kg (110 lbs.) at Screening;
All female subjects must have a negative pregnancy test at Screening and at each Check-in Visit; and one of the following:
Using a medically acceptable form of birth control for at least 1 month prior to first dose [e.g., hormonal contraceptives (oral, patch, injectable or vaginal ring), intrauterine device, or a double barrier method (e.g., diaphragm, cervical cap, oral, patch or vaginal hormonal contraceptive, condom, spermicide, or sponge)]
Documented as surgically sterile by hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/tubal occlusion) at least 6 months prior to the first dose;

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Postmenopausal (no menstruation for a minimum of 12 months and confirmed by FSH and estradiol at Screening);
Medically healthy based on medical history, vital sign measurements, clinical laboratory test results, and physical examination;
Non-smokers (including nicotine-containing products) for at least 6 continuous months prior to the first dose.
Be willing and able to consume all contents of the standardized high calorie, high fat breakfast within 30 minutes prior to dosing.

Who cannot join

Females who are pregnant, lactating, or planning to become pregnant during the study;
Life-time history and/or recent evidence of alcohol or drug/substance abuse disorder;
Subjects with history of hypersensitivity to cetirizine or hydroxyzine, or any component of the test and reference formulations;
Subjects who test positive at Screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody;
Subjects who test positive at Screening or at Check-in for alcohol and/or drugs of abuse;
Subjects who donated ≥ 500 mL of blood within 56 days prior to the first dose of study drug or ≥ 50 mL and ≤ 499 mL of blood within 30 days or plasma (e.g. plasmapheresis) within 14 days prior to the first dose of study drug;

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Use of prescription or non-prescription drugs, dietary supplements, or herbal supplements at the time of Screening and within 14 days prior to the first dose of the study drug;
Subjects who have a history of difficulty in donating blood or difficulty with phlebotomy procedures, and poor venous access;
Subjects who have participated in another clinical trial within 30 days prior to the first study period;
Member or first-degree relative of study staff or the Sponsor directly involved in the study;
Any condition which in the opinion of Investigator would interfere with the subject's ability to provide informed consent, comply with study instructions, confound interpretation of study results, or endanger the subject if he or she took part in the trial.

About this study

Official title: A Randomized, Open-Label, Single-Dose, Five-Period Crossover, Relative Bioavailability Study to Evaluate Cetirizine HCl Gummy 10 mg and Cetirizine HCl Oral Tablets 10 mg Administered in Healthy Adult Male and Female Subjects

Read the detailed description

Primary:

To determine the relative bioavailability of a single oral dose of cetirizine HCl Gummy 10 mg and cetirizine HCl oral tablets 10 mg administered under fasted conditions in healthy adult male and female subjects.

Secondary:

To determine the relative bioavailability of a single oral dose of cetirizine HCl Gummy 10 mg administered under fasted and fed conditions in healthy adult male and female subjects;
To determine the relative bioavailability of a single oral dose of cetirizine HCl Gummy 10 mg administered under fasted conditions with and without water in healthy adult male and female subjects;
To determine the relative bioavailability of a single oral dose of cetirizine HCl Gummy 10 mg administered under fasted conditions and chewed or swallowed whole in healthy adult male and female subjects.

Conditions: Allergy
Being tested: cetirizine HCl Gummy, Zyrtec tablet 10mg
Medical subject headings: Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

cetirizine HCl GummyDrug
Also called Ceteric Allergy Gummy
cetirizine HCl 10mg in a gummy formulation
Zyrtec tablet 10mgDrug
cetirizine HCl 10mg tablet

Study groups in NCT04071821
Study group	Role	What they receive
A: Test under Fasted Condition	Experimental	Single oral dose of cetirizine HCl Gummy 10 mg, chewed, administered with approximately 240 mL of room temperature water, under fasted conditions Receives: Drug: cetirizine HCl Gummy
B: Reference under Fasted Condition	Active comparator	Reference: Single oral dose of cetirizine HCl oral tablets 10 mg, administered with approximately 240 mL of room temperature water, under fasted conditions Receives: Drug: Zyrtec tablet 10mg
C: Test under Fed Condition	Experimental	Test: Single oral dose of cetirizine HCl Gummy 10 mg, chewed, administered with approximately 240 mL of room temperature water, under fed conditions Receives: Drug: cetirizine HCl Gummy
D: Test under Fasted Condition with No Water	Experimental	Single oral dose of cetirizine HCl Gummy 10 mg, chewed, administered with no water, under fasted conditions Receives: Drug: cetirizine HCl Gummy
E: Test Swallowed Whole with Water, under Fasted Condition	Experimental	Single oral dose of cetirizine HCl Gummy 10 mg, swallowed whole, administered with approximately 240 mL of room temperature water, under fasted conditions Receives: Drug: cetirizine HCl Gummy

What is being measured

The primary outcome is the main question the study is designed to answer.

maximum plasma cetirizine concentration (Cmax)
PK blood samples to measure plasma concentrations of cetirizine will be collected by direct venipuncture or by use of an indwelling cannula. Blood will be collected into tubes containing K2EDTA for determination of plasma cetirizine concentration at time 0 (within 60 minutes pre-dose), 10, 20 minute post-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36 hours post-dose. Plasma cetirizine concentrations will be listed at each time point by subject and summarized by treatment at each time point using descriptive statistics (n, mean, standard deviation (SD), Coefficient of variation (CV%), median, minimum and maximum values). Pharmacokinetic calculations will be performed based on actual time of blood sample collection, using non-compartmental methods with Phoenix WinNonlin Version 8.1 (Certara USA, Inc., Princeton, New Jersey, USA). Plots of mean concentrations of plasma cetirizine versus time will be generated and Cmax will be generated from the plot.
Measured: 2 months
area under the plasma drug concentration versus time curve (AUC)
AUC will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ). AUC will be calculated to the last measurable observation (AUC0-t) and extrapolated to infinity (AUC0 ∞).
Measured: 2 months

Secondary outcomes (3)

time to Cmax (Tmax)
Tmax will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ).
Measured: 2 months
elimination half-life (t½)
t½ will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ).
Measured: 2 months
terminal elimination rate constant (Kel).
Kel will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ).
Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202530 Sep 2025

First posted28 Aug 2019
Study start1 May 2025 (estimated)
Primary completion15 Jul 2025 (estimated)
Study completion30 Sep 2025 (estimated)

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: Randomized, Open-Label, Single-Dose, Five-Period Crossover
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04071821
Sponsor's protocol ID: P001-2019
Status last verified: Jun 2024
First submitted: 21 Aug 2019
Last updated: 13 Jun 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Allergy trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Single-Dose, Five-Period Crossover, Relative Bioavailability Study to Evaluate Cetirizine HCl Gummy 10 mg and Cetirizine HCl Oral Tablets 10 mg Administered in Healthy Adult Male and Female Subjects
ClinicalTrials.gov ID: NCT04071821
Acronym / sponsor ID: P001-2019
Conditions: Allergy
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 30 participants (estimated)
Lead sponsor: Seattle Gummy CompanyIndustry (pharma, biotech, devices)
Study start: 1 May 2025 (estimated)
Primary completion: 15 Jul 2025 (estimated)
Study completion: 30 Sep 2025 (estimated)
First posted: 28 Aug 2019 (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.

Detailed description

Primary:

To determine the relative bioavailability of a single oral dose of cetirizine HCl Gummy 10 mg and cetirizine HCl oral tablets 10 mg administered under fasted conditions in healthy adult male and female subjects.

Secondary:

To determine the relative bioavailability of a single oral dose of cetirizine HCl Gummy 10 mg administered under fasted and fed conditions in healthy adult male and female subjects;
To determine the relative bioavailability of a single oral dose of cetirizine HCl Gummy 10 mg administered under fasted conditions with and without water in healthy adult male and female subjects;
To determine the relative bioavailability of a single oral dose of cetirizine HCl Gummy 10 mg administered under fasted conditions and chewed or swallowed whole in healthy adult male and female subjects.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5
Model description: Randomized, Open-Label, Single-Dose, Five-Period Crossover

Arm	Type	Receives
A: Test under Fasted Condition	Experimental	Drug: cetirizine HCl GummySingle oral dose of cetirizine HCl Gummy 10 mg, chewed, administered with approximately 240 mL of room temperature water, under fasted conditions
B: Reference under Fasted Condition	Active comparator	Drug: Zyrtec tablet 10mgReference: Single oral dose of cetirizine HCl oral tablets 10 mg, administered with approximately 240 mL of room temperature water, under fasted conditions
C: Test under Fed Condition	Experimental	Drug: cetirizine HCl GummyTest: Single oral dose of cetirizine HCl Gummy 10 mg, chewed, administered with approximately 240 mL of room temperature water, under fed conditions
D: Test under Fasted Condition with No Water	Experimental	Drug: cetirizine HCl GummySingle oral dose of cetirizine HCl Gummy 10 mg, chewed, administered with no water, under fasted conditions
E: Test Swallowed Whole with Water, under Fasted Condition	Experimental	Drug: cetirizine HCl GummySingle oral dose of cetirizine HCl Gummy 10 mg, swallowed whole, administered with approximately 240 mL of room temperature water, under fasted conditions

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Are capable of giving informed consent and complying with study procedures;
Male or female, 18 to 55 years of age, inclusive, at date of consent;
Body mass index (BMI) ≥ 18.0 to ≤ 32.0 kg/m2 and total body weight > 50 kg (110 lbs.) at Screening;
All female subjects must have a negative pregnancy test at Screening and at each Check-in Visit; and one of the following:
Medically healthy based on medical history, vital sign measurements, clinical laboratory test results, and physical examination;

Key exclusion criteria (11 listed)

Females who are pregnant, lactating, or planning to become pregnant during the study;
Life-time history and/or recent evidence of alcohol or drug/substance abuse disorder;
Subjects with history of hypersensitivity to cetirizine or hydroxyzine, or any component of the test and reference formulations;
Subjects who test positive at Screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody;
Subjects who test positive at Screening or at Check-in for alcohol and/or drugs of abuse;

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 HCl GummyAlso: Ceteric Allergy Gummycetirizine HCl 10mg in a gummy formulation	Drug	A: Test under Fasted Condition, C: Test under Fed Condition, D: Test under Fasted Condition with No Water, E: Test Swallowed Whole with Water, under Fasted Condition
Zyrtec tablet 10mgcetirizine HCl 10mg tablet	Drug	B: Reference under Fasted Condition

Primary outcome

maximum plasma cetirizine concentration (Cmax)
Time frame: 2 months
PK blood samples to measure plasma concentrations of cetirizine will be collected by direct venipuncture or by use of an indwelling cannula. Blood will be collected into tubes containing K2EDTA for determination of plasma cetirizine concentration at time 0 (within 60 minutes pre-dose), 10, 20 minute post-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36 hours post-dose. Plasma cetirizine concentrations will be listed at each time point by subject and summarized by treatment at each time point using descriptive statistics (n, mean, standard deviation (SD), Coefficient of variation (CV%), median, minimum and maximum values). Pharmacokinetic calculations will be performed based on actual time of blood sample collection, using non-compartmental methods with Phoenix WinNonlin Version 8.1 (Certara USA, Inc., Princeton, New Jersey, USA). Plots of mean concentrations of plasma cetirizine versus time will be generated and Cmax will be generated from the plot.
area under the plasma drug concentration versus time curve (AUC)
Time frame: 2 months
AUC will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ). AUC will be calculated to the last measurable observation (AUC0-t) and extrapolated to infinity (AUC0 ∞).

3 secondary outcomes

time to Cmax (Tmax)
Time frame: 2 months
elimination half-life (t½)
Time frame: 2 months
terminal elimination rate constant (Kel).
Time frame: 2 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
Individual participant dataSharing planned: No

Related trials for Allergy

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
RecruitingPhase 1
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing cetirizine HCl Gummy and Zyrtec tablet 10mg in people with Allergy, run by Seattle Gummy Company.

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 10 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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 plasma cetirizine concentration (Cmax) (time frame: 2 months). 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?

On the ClinicalTrials.gov record for NCT04071821.

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 13 Jun 2024.