NCT04071821

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Seattle Gummy Company · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• Allergy

Interventions

Type	Name	Description
DRUG	cetirizine HCl Gummy	cetirizine HCl 10mg in a gummy formulation
DRUG	Zyrtec tablet 10mg	cetirizine HCl 10mg tablet

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-07-15
• Completion: 2025-09-30
• First posted: 2019-08-28
• Last updated: 2024-06-13

Regulatory

• FDA-regulated drug study