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;
Crossover
cetirizine HCl Gummy
Drugcetirizine HCl 10mg in a gummy formulation
Zyrtec tablet 10mg
Drugcetirizine HCl 10mg tablet
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.
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 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).
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).
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).
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
