Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Desloratadine · 6 trials · 3 indications
| 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 |
| Desloratadine Tablets, 5 mg | EXPERIMENTAL | Desloratadine Tablets, 5 mg of Dr. Reddy's Laboratories |
| 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...
Desloratadine is an investigational small molecule being studied in Phase 1 clinical trials for use in healthy volunteers under fed and fasting conditions. It is being developed by Dr. Reddy's Laboratories Ltd (RDY) as a generic version of the antihistamine desloratadine, which is used to treat allergies.
Desloratadine is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company traded on the NYSE under the ticker RDY. The company is conducting Phase 1 bioequivalence studies to compare its desloratadine tablets with reference products.
Desloratadine is in Phase 1 clinical development. All four clinical trials listed for this drug are Phase 1 studies that have been completed. The drug is investigational and has not been approved by the FDA for marketing.
Desloratadine has been studied in four completed Phase 1 trials: NCT01314352, NCT01506037, NCT01506050, and NCT01506791. These trials assessed the bioavailability and bioequivalence of desloratadine tablets under fed and fasting conditions in healthy volunteers.
Desloratadine is the generic name for the antihistamine drug marketed as Clarinex. Dr. Reddy's Laboratories is developing a generic version of desloratadine, which is the active ingredient in Clarinex, used to treat allergic rhinitis and hives.