Relative Bioavailability Study to Evaluate Cetirizine HCl Gummy 10 mg and Cetirizine HCl Oral Tablets 10 mg
Launched by SEATTLE GUMMY COMPANY · Aug 26, 2019
Trial Information
Current as of June 02, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is designed to compare two forms of cetirizine, a medication commonly used to treat allergies: a gummy version and a traditional oral tablet. The study aims to see how well each form of the medication is absorbed in the body. It will involve healthy adult men and women aged 18 to 55 who meet certain health criteria. Participants will be asked to take one of the forms of cetirizine in a controlled setting and will be monitored for how the body processes the medication.
To qualify for this study, participants must be in good health, have a body weight over 110 pounds, and not smoke. Women must have a negative pregnancy test and use effective birth control if they are not postmenopausal. Participants will need to follow specific instructions, such as eating a high-calorie breakfast before taking the medication. This trial is not yet recruiting, but it’s important for potential participants to know that they will be closely monitored throughout the study to ensure safety and gather accurate results.
Gender
ALL
Eligibility 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.
About Seattle Gummy Company
Seattle Gummy Company is a pioneering organization dedicated to advancing health and wellness through innovative gummy-based dietary supplements. With a commitment to quality and efficacy, the company leverages cutting-edge research and development to create products that not only meet the highest industry standards but also enhance the consumer experience. As a clinical trial sponsor, Seattle Gummy Company actively collaborates with healthcare professionals and researchers to evaluate the safety and effectiveness of its formulations, ensuring that its offerings are backed by robust scientific evidence. Through these efforts, the company aims to contribute to the growing body of knowledge in the nutraceutical field while providing consumers with effective solutions for their health needs.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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