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Label indication CLARINEX is a histamine-1 (H1) receptor antagonist indicated for: Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 2 years of age and older. ( 1.1 ) Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 6 months of age and older. FDA label
Desloratadine · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Desloratadine Tablets, 5 mg | EXPERIMENTAL | Desloratadine Tablets, 5 mg of Dr. Reddy's Laboratories |
| Clarinex | ACTIVE_COMPARATOR | Clarinex® 5 mg Tablets of Schering-Plough |
| Name | Type | Description |
|---|---|---|
| Desloratadine | DRUG | Desloratadine Tablets, 5 mg |
Inclusion Criteria: * Is the individual a healthy, normal adult man and women who volunteers to participate? * Is s/he within 18 and 45 years of age, inclusive? * Is his/her BMI between 19 and 30, inclusive? * Is she willing to avoid pregnancy by abstaining from sexual intercourse with a non-steril...
Desloratadine is a small molecule drug developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. It is an HRH1 antagonist. The program has been studied in Phase 1 clinical development, and the trials listed for it were conducted in the United States in healthy adult volunteers.
Desloratadine targets HRH1, the histamine H1 receptor, and acts as an antagonist at that receptor. This target class places it among histamine H1 receptor antagonists. The drug is a small molecule modality, and its development work has focused on Phase 1 bioavailability testing of a 5 mg tablet formulation.
Desloratadine is developed by Dr. Reddy's Laboratories Ltd, which is publicly traded under the ticker RDY. The company sponsored the Phase 1 bioavailability studies of its desloratadine 5 mg tablets. Both listed trials were conducted in the United States and enrolled healthy adult volunteers.
Desloratadine is in Phase 1 development. The program includes one completed Phase 1 trial with 28 participants, and the studies were randomized, active controlled, and conducted in healthy volunteers. The trials evaluated the 5 mg tablet formulation under fed and fasting conditions.
Desloratadine has been studied in two completed Phase 1 bioavailability trials: NCT01314352, which tested the 5 mg tablet under fed conditions, and NCT01314339, which tested the same tablet under fasting conditions. Each trial enrolled 28 healthy adult volunteers in the United States, and both are listed as completed.