NCT06284902

Bioavailability Study of Fexofenadine HCl New Formulation Tablet

Open-Label, Single-Dose, Randomized, 6-Treatment, 6-Sequence, 6-Period Crossover Relative Bioavailability Study Comparing Fexofenadine HCl New Formulation Tablets (Test Drug) With or Without Water to Fexofenadine HCl Coated Tablets (Reference Drug) With Water in Healthy Male and Female Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Opella Healthcare Group SAS, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to assess the relative bioavailability of a new galenic form of fexofenadine HCl new formulation tablet (test drug) taken with or without water compared to fexofenadine HCl film-coated tablets (reference form) taken with water under fasting conditions.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Fexofenadine HCl Coated tablet	Film-coated tablet.
DRUG	Fexofenadine HCl New Formulation Tablet	New formulation tablet.

Timeline

• Start date: 2024-02-23
• Primary completion: 2024-05-08
• Completion: 2024-05-23
• First posted: 2024-02-29
• Last updated: 2025-09-12

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study