Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00835276 | Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 60 | — | — | Mar 1, 2002 | Mar 1, 2002 | Aug 20, 2009 | 1 | United States |
| NCT00835640 | Fexofenadine Hydrochloride 180 mg Tablets Under Non-Fasting Conditions | PHASE1 | COMPLETED | 24 | — | — | Jan 1, 2002 | Jan 1, 2002 | Aug 20, 2009 | 1 | United States |
Bioequivalence based on Cmax.
Bioequivalence based on AUC0-t.
Bioequivalence based on AUC0-inf.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Fexofenadine 180 mg tablets | DRUG | 1 x 180 mg |
| ALLEGRA® 180 mg tablets | DRUG | 1 x 180 mg |
Inclusion Criteria: * All volunteers selected for this study will be healthy, non-smoking men and women 18 to 55 years of age, inclusive, at the time of dosing. The volunteer's body mass index (BMI) is less that or equal to 30. * If female and : * of child bearing potential, is practicing an acc...