Bioavailability Study of Fexofenadine HCl New Formulation Tablet

NCT06284902 | Completed Phase 1 FDA Drug

• 1 other identifier: BDR17987
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

• Terminal Elimination Rate Constant (Kel) 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

• Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)

  From screening up to 7-10 days post last dose (approximately 13 weeks)

Study Arms (6)

Treatment Sequence Group 1

EXPERIMENTAL

Drug: Fexofenadine HCl Coated tablet; Drug: Fexofenadine HCl New Formulation Tablet

Treatment Sequence Group 2

EXPERIMENTAL

Drug: Fexofenadine HCl Coated tablet; Drug: Fexofenadine HCl New Formulation Tablet

Treatment Sequence Group 3

EXPERIMENTAL

Drug: Fexofenadine HCl Coated tablet; Drug: Fexofenadine HCl New Formulation Tablet

Treatment Sequence Group 4

EXPERIMENTAL

Drug: Fexofenadine HCl Coated tablet; Drug: Fexofenadine HCl New Formulation Tablet

Treatment Sequence Group 5

EXPERIMENTAL

Drug: Fexofenadine HCl Coated tablet; Drug: Fexofenadine HCl New Formulation Tablet

Treatment Sequence Group 6

EXPERIMENTAL

Drug: Fexofenadine HCl Coated tablet; Drug: Fexofenadine HCl New Formulation Tablet

Interventions

Fexofenadine HCl Coated tablet DRUG

Film-coated tablet.

Treatment Sequence Group 1; Treatment Sequence Group 2; Treatment Sequence Group 3; Treatment Sequence Group 4; Treatment Sequence Group 5; Treatment Sequence Group 6

Fexofenadine HCl New Formulation Tablet DRUG

New formulation tablet.

Treatment Sequence Group 1; Treatment Sequence Group 2; Treatment Sequence Group 3; Treatment Sequence Group 4; Treatment Sequence Group 5; Treatment Sequence Group 6

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 ≤90.0 kg for females.
• Healthy as defined by:
• the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
• Standard 12-lead electrocardiogram (ECG) parameters after 5 minutes resting in supine position in the following ranges:120 milliseconds (ms)\<PR\<220 ms, QRS\<120 ms, QTcF≤450 ms if male, ≤470 ms if female and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.
• Female participants of non-childbearing potential must be:
• simultaneous use of condom and hormonal contraceptive (e.g., oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device used for at least 4 weeks prior to sexual intercourse for the female partner;
• simultaneous use of condom and a diaphragm or cervical cap with spermicide for the female partner.
• Male participants (including men who have had a vasectomy) with a pregnant partner must agree to use a condom from the first dose and for 90 days after the last dose.
• Male participants must be willing not to donate sperm for 90 days after the last dose.
• Willing to take off dentures or mouth piercing at the time of dosing.
• Able to understand the study procedures and provide signed informed consent to participate in the study.

You may not qualify if:

• Any clinically significant abnormal finding at physical examination at screening.
• Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody at screening.
• Frequent history of headaches and/or migraine more than twice a month, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
• Positive pregnancy test or lactating female participant.
• Positive urine drug screen, urine cotinine test, or alcohol breath test.
• Known allergic reactions to fexofenadine HCl or other related drugs, or to any excipient in the formulation.
• Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
• Clinically significant ECG abnormalities or vital signs abnormalities (systolic blood pressure lower than 95 or over 140 mmHg, diastolic blood pressure lower than 45 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
• Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease of ≥20 mmHg in systolic blood pressure, decrease of ≥10 mmHg in diastolic blood pressure, and increase of ≥30 bpm in heart rate within 3 minutes when changing from supine to standing position.
• History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine \[PCP\], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.
• History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 10 units for women or 15 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
• Use of medications for the timeframes specified below, with the exception of hormonal contraceptives and medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the pharmacokinetic (PK) profile of the study drug or participant safety (e.g., topical drug products without significant systemic absorption):
• Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day).
• Presence of orthodontic braces or orthodontic retention wires or dentures, or any physical findings in the mouth or tongue that would be likely to interfere with successful completion of the dosing procedure.
• Presents difficulty with venipuncture and/or poor venous access.

Sponsors & Collaborators

• Opella Healthcare Group SAS, a Sanofi Company: lead

Study Sites (1)

Syneos Health Clinic inc.

Québec, Quebec, G1P 0A2, Canada

Location

Related Links

• BDR17987 Plain Language Results Summary

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: February 23, 2024
• Primary Completion: May 8, 2024
• Study Completion: May 23, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)