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Antihistamine

Treatment Sequence Group 3 for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Opella Healthcare Group SAS, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

Study Summary

This trial aims to compare how well a new tablet of fexofenadine HCl works when taken with or without water, to the traditional film-coated tablets of fexofenad

Who is the study for?
This trial is for healthy non-smoking adults aged 18-55 with a BMI between >18 and <29.9 kg/m^2, weighing 50-100 kg for males and 40-90 kg for females. Participants should have no significant medical history or recent surgeries, be post-menopausal or surgically sterile if female, and agree to use specific contraception methods.Check my eligibility
What is being tested?
The study aims to compare the body's absorption of a new tablet form of Fexofenadine HCl (test drug) taken with or without water against the standard coated tablet (reference) taken with water when fasting.See study design
What are the potential side effects?
While not specified here, common side effects of Fexofenadine can include headache, drowsiness, nausea, and dizziness. The new formulation may have similar effects; participants will be monitored for any adverse reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-t) of Fexofenadine
Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) (AUC0-inf) of Fexofenadine
Maximal Observed Concentration (Cmax) of Fexofenadine
Secondary outcome measures
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
Terminal Elimination Rate Constant (Kel) of Fexofenadine
Terminal Half-life Associated with the Terminal Slope (T1/2z) of Fexofenadine
+2 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Treatment Sequence Group 6Experimental Treatment2 Interventions
Group II: Treatment Sequence Group 5Experimental Treatment2 Interventions
Group III: Treatment Sequence Group 4Experimental Treatment2 Interventions
Group IV: Treatment Sequence Group 3Experimental Treatment2 Interventions
Group V: Treatment Sequence Group 2Experimental Treatment2 Interventions
Group VI: Treatment Sequence Group 1Experimental Treatment2 Interventions

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Opella Healthcare Group SAS, a Sanofi CompanyLead Sponsor
3 Previous Clinical Trials
207 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
864 Previous Clinical Trials
2,020,372 Total Patients Enrolled
~17 spots leftby Jun 2025
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