Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zyrtec · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Cetirizine HCl Tablets 10 mg |
| 2 | ACTIVE_COMPARATOR | Zyrtec® 10 mg |
| Name | Type | Description |
|---|---|---|
| Cetirizine HCl Tablets 10 mg | DRUG | 10mg, single dose fed |
| Zyrtec® 10 mg | DRUG | 10mg, single dose fed |
| Zyrtec® Tablets 10 mg | DRUG | 10mg, single dose fasting |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum beta-human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to the start of the study and the evening prior ...
Zyrtec is an antihistamine used to relieve allergy symptoms such as sneezing, runny nose, and itchy or watery eyes. It is being studied in healthy volunteers to assess the bioavailability of a generic cetirizine HCl tablet compared to the brand-name product.
Zyrtec is developed by Viatris Inc., a global healthcare company traded on the NASDAQ under the ticker VTRS. The company is conducting clinical studies to evaluate the pharmacokinetics of cetirizine HCl tablets.
Zyrtec is in Phase 1 clinical development. Two Phase 1 studies have been completed in healthy adult volunteers to compare the absorption of a generic cetirizine HCl tablet with the reference Zyrtec product.
Zyrtec has been studied in two completed Phase 1 trials: NCT00649857, a food study of cetirizine HCl tablets 10 mg and Zyrtec 10 mg, and NCT00650065, a fasting study of the same products. Both enrolled healthy adults in the United States.
Zyrtec is the brand name for cetirizine HCl, an antihistamine. The clinical trials compare the generic cetirizine HCl tablets with the brand-name Zyrtec to ensure they are bioequivalent.