Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the single-dose and steady-state pharmacokinetics of desloratadine and fexofenadine in desloratadine slow metabolizers. To evaluate the safety and tolerability of desloratadine compared to fexofenadine following single and multiple oral doses administered to desloratadine slow metabolizers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fexofenadine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Endpoints will be the AUC and Cmax for desloratadine, 3-OH desloratadine, and fexofenadine. | Serial, Trough, and Terminal blood samples over 8 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Endpoints will include Tmax, elimination half-life (t1/2), and accumulation index, as the data permit. | Serial, Trough, and Terminal blood samples over 8 days. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Phyllis Diener | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis | Bridgewater | New Jersey | 08807 | United States |
Not provided
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
Not provided
Not provided
| ID | Term |
|---|---|
| C093230 | fexofenadine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |