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Bioavailability Study of Fexofenadine HCl New Formulation Tablet

NCT06284902 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-09-12

No results posted yet for this study

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

DRUG

Fexofenadine HCl Coated tablet

Film-coated tablet.

DRUG

Fexofenadine HCl New Formulation Tablet

New formulation tablet.

Sponsors & Collaborators

  • Opella Healthcare Group SAS, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-23
Primary Completion
2024-05-08
Completion
2024-05-23
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06284902 on ClinicalTrials.gov