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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence Group 1 | Experimental |
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| Treatment Sequence Group 2 | Experimental |
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| Treatment Sequence Group 3 | Experimental |
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| Treatment Sequence Group 4 | Experimental |
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| Treatment Sequence Group 5 | Experimental |
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| Treatment Sequence Group 6 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fexofenadine HCl Coated tablet | Drug | Film-coated tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
Standard 12-lead electrocardiogram (ECG) parameters after 5 minutes resting in supine position in the following ranges:120 milliseconds (ms)\
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syneos Health Clinic inc. | Québec | Quebec | G1P 0A2 | Canada |
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| Label | URL |
|---|---|
| BDR17987 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| Fexofenadine HCl New Formulation Tablet | Drug | New formulation tablet. |
|
| 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) | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical trial participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. A TEAE is defined as AEs that occurred or worsened at any time during the on-treatment period are defined as treatment-emergent adverse events. | From screening up to 7-10 days post last dose (approximately 13 weeks) |