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Fexofenadine Coated

Phase 1

Healthy Volunteers | Small molecule | Other |Sanofi|Last Updated: Sep 12, 2025

Target and mechanism

ModalitySmall molecule

Also known as Fexofenadine HCl Coated tablet

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED

Total Trials1

Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

Fexofenadine Coated · 1 trial · 1 indication

Phase 1 1

NCT06284902Bioavailability Study of Fexofenadine HCl New Formulation TabletHealthy Volunteers

COMPLETED25 Analytics

PHASE1COMPLETED

Bioavailability Study of Fexofenadine HCl New Formulation Tablet

Healthy Volunteers

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Study Endpoints

Primary Endpoints

Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-t) of Fexofenadine

Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hours (hrs) post-dose

Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) (AUC0-inf) of Fexofenadine

Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose

Maximal Observed Concentration (Cmax) of Fexofenadine

Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose

Secondary Endpoints

Time When the Maximal Concentration is Observed (Tmax) of Fexofenadine

Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose

Time of Observation Prior to the First Observation with a Measurable (non-zero) Concentration (Tlag) of Fexofenadine

Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose

Terminal Half-life Associated with the Terminal Slope (T1/2z) of Fexofenadine

Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose

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Study Design & Arms

AllocationRANDOMIZED

MaskingNONE

ModelCROSSOVER

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
Treatment Sequence Group 1	EXPERIMENTAL	-
Treatment Sequence Group 2	EXPERIMENTAL	-
Treatment Sequence Group 3	EXPERIMENTAL	-
Treatment Sequence Group 4	EXPERIMENTAL	-
Treatment Sequence Group 5	EXPERIMENTAL	-
Treatment Sequence Group 6	EXPERIMENTAL	-

Interventions

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

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Eligibility Criteria

Age Range18 Years to 55 Years

SexALL

Healthy VolunteersYes

Study Sites1

Inclusion Criteria: 1. Male or female non-smokers (no use of tobacco or nicotine products within 3 months prior to screening), ≥18 and ≤55 years of age, with body-mass-index (BMI) \>18 and \<29.9 kilogram per meter square (kg/m\^2) and body weight ≥50.0 kg to ≤100.0 kg for males and ≥40.0 kg to ≤90...

Countries:Canada

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