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Not yet recruitingNCT04071821Updated Jun 13, 2024

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

A Phase 1 interventional study of cetirizine HCl Gummy and Zyrtec tablet 10mg in Allergy, sponsored by Seattle Gummy Company. Not yet recruiting. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-13.

Sponsored by Seattle Gummy Company · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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 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.
02

Conditions studied

  • Allergy
03

In context

Lead sponsor

Seattle Gummy Company is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Are capable of giving informed consent and complying with study procedures;
  2. Male or female, 18 to 55 years of age, inclusive, at date of consent;
  3. Body mass index (BMI) ≥ 18.0 to ≤ 32.0 kg/m2 and total body weight > 50 kg (110 lbs.) at Screening;

  4. All female subjects must have a negative pregnancy test at Screening and at each Check-in Visit; and one of the following:

    1. 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)]
    2. 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;
    3. Postmenopausal (no menstruation for a minimum of 12 months and confirmed by FSH and estradiol at Screening);
  5. Medically healthy based on medical history, vital sign measurements, clinical laboratory test results, and physical examination;
  6. Non-smokers (including nicotine-containing products) for at least 6 continuous months prior to the first dose.
  7. Be willing and able to consume all contents of the standardized high calorie, high fat breakfast within 30 minutes prior to dosing.

Exclusion criteria

Exclusion Criteria:

  1. Females who are pregnant, lactating, or planning to become pregnant during the study;
  2. Life-time history and/or recent evidence of alcohol or drug/substance abuse disorder;
  3. Subjects with history of hypersensitivity to cetirizine or hydroxyzine, or any component of the test and reference formulations;
  4. Subjects who test positive at Screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody;
  5. Subjects who test positive at Screening or at Check-in for alcohol and/or drugs of abuse;
  6. 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;
  7. 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;
  8. Subjects who have a history of difficulty in donating blood or difficulty with phlebotomy procedures, and poor venous access;
  9. Subjects who have participated in another clinical trial within 30 days prior to the first study period;
  10. Member or first-degree relative of study staff or the Sponsor directly involved in the study;
  11. 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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    A: Test under Fasted Condition

    Single oral dose of cetirizine HCl Gummy 10 mg, chewed, administered with approximately 240 mL of room temperature water, under fasted conditions

    Drug: cetirizine HCl Gummy

  • Active comparator
    B: Reference under Fasted Condition

    Reference: Single oral dose of cetirizine HCl oral tablets 10 mg, administered with approximately 240 mL of room temperature water, under fasted conditions

    Drug: Zyrtec tablet 10mg

  • Experimental
    C: Test under Fed Condition

    Test: Single oral dose of cetirizine HCl Gummy 10 mg, chewed, administered with approximately 240 mL of room temperature water, under fed conditions

    Drug: cetirizine HCl Gummy

  • Experimental
    D: Test under Fasted Condition with No Water

    Single oral dose of cetirizine HCl Gummy 10 mg, chewed, administered with no water, under fasted conditions

    Drug: cetirizine HCl Gummy

  • Experimental
    E: Test Swallowed Whole with Water, under Fasted Condition

    Single oral dose of cetirizine HCl Gummy 10 mg, swallowed whole, administered with approximately 240 mL of room temperature water, under fasted conditions

    Drug: cetirizine HCl Gummy

Interventions

  • Drugcetirizine HCl Gummy

    cetirizine HCl 10mg in a gummy formulation

    Also known as: Ceteric Allergy Gummy

  • DrugZyrtec tablet 10mg

    cetirizine HCl 10mg tablet

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 months

  2. 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 ∞).

    Time frame: 2 months

Secondary outcomes

  1. 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).

    Time frame: 2 months

  2. 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).

    Time frame: 2 months

  3. 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).

    Time frame: 2 months

Other outcomes

  1. incidence of treatment-emergent adverse events (TEAE)

    Adverse events (AE) will be coded using a standardized Medical Dictionary for Regulatory Activities (MedDRA), Version 22,0 or higher. All treatment-emergent adverse events (TEAE) will be documented throughout the study from the time a subject receives the first dose of study drug until 7 days after the subject receives the last dose of study drug.

    Time frame: 2 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

  • Study protocol · Jul 28, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04071821
Lead sponsor
Seattle Gummy Company
Responsible party
Sponsor
First posted
Aug 28, 2019
Start date
May 1, 2025 (estimated)
Primary completion
Jul 15, 2025 (estimated)
Completion
Sep 30, 2025 (estimated)
Last update
Jun 13, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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