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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01373138 | Bioequivalence Study of Desloratadine and Pseudoephedrine Sulfate Extended-release Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 34 | — | — | Apr 1, 2006 | May 1, 2006 | Jun 14, 2011 | 1 | Canada |
| NCT01506791 | Bioequivalence Study of Desloratadine and Pseudoephedrine Extended-release Tablets Under Fed Conditions | PHASE1 | COMPLETED | 44 | — | — | Apr 1, 2006 | Apr 1, 2006 | Jan 10, 2012 | 1 | United States |
| NCT01506037 | Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fed Condition | PHASE1 | COMPLETED | 36 | — | — | Jan 1, 2006 | Feb 1, 2006 | Jan 11, 2012 | 1 | United States |
| NCT01506050 | Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fasting Condition | PHASE1 | COMPLETED | 35 | — | — | Jan 1, 2006 | Feb 1, 2006 | Jan 9, 2012 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Desloratadine and pseudoephedrine ER tablets 5/240 mg | EXPERIMENTAL | Desloratadine and pseudoephedrine ER tablets 5/240 mg of Dr. Reddy's Laboratories Limited |
| Clarinex D 24-hour | ACTIVE_COMPARATOR | Clarinex D-24 of Schering Corporation Inc USA |
| Desloratadine OD tablets 5 mg | EXPERIMENTAL | Desloratadine OD tablets 5 mg of Dr. Reddy's Laboratories Limited |
| Clarinex | ACTIVE_COMPARATOR | Clarinex 5 mg of Schering Corporation Inc USA |
| Name | Type | Description |
|---|---|---|
| Desloratadine and pseudoephedrine | DRUG | Desloratadine and pseudoephedrine 5/240 mg |
| Desloratadine | DRUG | Desloratadine ODT 5 mg |
Inclusion Criteria: * Male or female, non-smoker, ≥18 and ≤45 years of age. * Capable of consent. * Medically healthy with clinically normal laboratory profile, vital signs and ECG. * BMI ≥19.0 and ≤30.0. Exclusion Criteria: * Clinically significant illness or surgery within 4 weeks prior to dosi...