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
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;
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)]
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;