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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Allergy
• Intervention / Treatment: Drug: cetirizine HCl Gummy; Drug: Zyrtec tablet 10mg

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; cetirizine HCl 10mg in a gummy formulation; Other Names: Ceteric Allergy 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; cetirizine HCl 10mg tablet
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; cetirizine HCl 10mg in a gummy formulation; Other Names: Ceteric Allergy 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; cetirizine HCl 10mg in a gummy formulation; Other Names: Ceteric Allergy 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; cetirizine HCl 10mg in a gummy formulation; Other Names: Ceteric Allergy Gummy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 ∞).	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	2 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 months

Collaborators and Investigators

• Sponsor: Seattle Gummy Company
• Collaborators: Frontage Clinical Services, Inc.; Frontage Laboratories, Inc.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2023
• Primary Completion (ANTICIPATED): December 15, 2023
• Study Completion (ANTICIPATED): April 30, 2024

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (ACTUAL): August 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Cetirizine
• Other Study ID Numbers: P001-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No