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Levocetirizine DiHCl · 2 trials · 2 indications
| 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 being developed by Dr. Reddy's Laboratories Ltd for use in healthy volunteers under fasting and fed conditions. It is currently in Phase 1 clinical development, with studies focused on bioequivalence of the 5mg tablet formulation.
Levocetirizine DiHCl is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company is conducting Phase 1 clinical trials to evaluate the bioequivalence of its 5mg tablet formulation.
Levocetirizine DiHCl is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing development includes bioequivalence studies in healthy volunteers under fasting and fed conditions.
Levocetirizine DiHCl has been studied in two completed Phase 1 clinical trials: NCT01506063, a bioequivalence study under fed conditions with 31 participants, and NCT01506076, a bioequivalence study under fasting conditions with 29 participants. Both trials were conducted in India with healthy volunteers aged 18 years and older.
Levocetirizine DiHCl is the dihydrochloride salt form of levocetirizine, an antihistamine. The drug is being developed as a 5mg tablet by Dr. Reddy's Laboratories Ltd. The clinical trials are designed to assess bioequivalence of this specific formulation.