Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04071821
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : October 23, 2020
Sponsor:
Collaborators:
Frontage Clinical Services, Inc.
Frontage Laboratories, Inc.
Information provided by (Responsible Party):
Seattle Gummy Company

Brief 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

Condition or disease Intervention/treatment Phase
Allergy Drug: cetirizine HCl Gummy Drug: Zyrtec tablet 10mg Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, Open-Label, Single-Dose, Five-Period Crossover
Masking: None (Open Label)
Primary Purpose: Other
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
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: Ceteric Allergy Gummy




Primary Outcome Measures :
  1. 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.

  2. 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 ∞).


Secondary Outcome Measures :
  1. time to Cmax (Tmax) [ Time Frame: 2 months ]
    Tmax will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ).

  2. elimination half-life (t½) [ Time Frame: 2 months ]
    t½ will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ).

  3. terminal elimination rate constant (Kel). [ Time Frame: 2 months ]
    Kel will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ).


Other Outcome Measures:
  1. incidence of treatment-emergent adverse events (TEAE) [ Time Frame: 2 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 Documents (Full-Text)

Documents provided by Seattle Gummy Company:
Study Protocol  [PDF] July 28, 2019

Layout table for additonal information
Responsible Party: Seattle Gummy Company
ClinicalTrials.gov Identifier: NCT04071821    
Other Study ID Numbers: P001-2019
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cetirizine
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs