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Label indication XYZAL is a histamine H 1 -receptor antagonist indicated for: The relief of symptoms associated with perennial allergic rhinitis ( 1.1 ) The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ( 1.2 ) 1.1 Perennial Allergic Rhinitis XYZAL is indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. FDA label
Also known as XYZAL
Levocetirizine DiHCl · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Levocetirizine DiHCl Tablets, 5 mg | EXPERIMENTAL | Levocetirizine DiHCl Tablets, 5 mg of Dr. Reddy's Laboratories Ltd. |
| XYZAL | ACTIVE_COMPARATOR | XYZAL Tablets 5 mg of UCB Farchim S.A. |
| Name | Type | Description |
|---|---|---|
| Levocetirizine DiHCl | DRUG | Levocetirizine DiHCl Tablets 5 mg |
Inclusion Criteria: * Subjects will provide written informed consent. * Subjects must be healthy adults within 18-45 years of age (inclusive). * Body mass index of ≥18.5 kg/m2 and ≤25 kg/m2, with body weight not less than 50 kg. * Subjects must be of normal health as determined by medical history a...
Levocetirizine DiHCl is a small molecule drug developed by Dr. Reddy's Laboratories Ltd. It is being studied in a Phase 1 bioequivalence trial under fasting conditions. The drug is an HRH1 antagonist. It has been evaluated in one completed clinical trial with 29 healthy volunteers in India.
Levocetirizine DiHCl targets HRH1, the histamine H1 receptor. It acts as an antagonist at this receptor. This mechanism is consistent with its classification as an antihistamine small molecule. The target class is antagonist, meaning it blocks the receptor rather than activating it.
Levocetirizine DiHCl is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is conducting clinical development of this small molecule drug. The Phase 1 trial was run in India. Dr. Reddy's is the sponsor of the study.
Levocetirizine DiHCl is in Phase 1 clinical development. It is investigational and has been tested in one completed Phase 1 trial. That trial enrolled 29 healthy volunteers and was active-controlled and randomized. No active trials are currently listed for this drug.
Levocetirizine DiHCl has been studied in one clinical trial, NCT01506076, titled Bioequivalence Study of Levocetirizine DiHCl Tablets 5mg of Dr. Reddy's Under Fasting Conditions. The trial was Phase 1, completed, and enrolled 29 healthy volunteers in India. It was randomized and active-controlled but not double-blind.
Levocetirizine DiHCl was evaluated in a Phase 1 bioequivalence study under fasting conditions. The trial involved healthy volunteers and was designed to compare the drug's behavior in the body. The study has been completed. No approved indication is stated for this specific development program.