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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01506076 | Bioequivalence Study of Levocetirizine DiHCl Tablets 5mg of Dr. Reddy's Under Fasting Conditions | PHASE1 | COMPLETED | 29 | — | — | Dec 1, 2007 | Jan 1, 2008 | Jan 9, 2012 | 1 | India |
| 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...