Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Not yet marketed
Cetirizine · 2 trials · 1 indication
The maximum observed plasma concentration.
Area under the plasma concentration versus time curve from start of drug administration until last measurable concentration.
Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, measured in nanograms/milliliter (ng/mL)
Bioavailability \[AUC(0-t)\] is a measure of how much of the drug reaches the person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The Area Under the Curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour \* nanograms (ng) per milliliter (mL).
Bioavailability Extrapolated to Infinity \[AUC (0-∞)\] is a calculated measure of how much of the drug will ever reach the person's bloodstream for the body to use. AUC (0-∞) stands for the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (forever). It is obtained from calculating AUC (0-t) plus AUC (t-∞).
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | Single dose of 10 mg cetirizine as a chewable tablet, administered orally after a 10-hour overnight fast and followed with 240 mL ambient water. Subjects will be instructed to chew the tablet completely before swallowing. |
| Treatment B | EXPERIMENTAL | Single dose of 10 mg cetirizine as a chewable tablet, administered orally after a 10-hour overnight fast without water. Subjects will be instructed to chew the tablet completely before swallowing. |
| Treatment C | EXPERIMENTAL | Single dose of 10 mg cetirizine as a chewable tablet, administered orally after a 10-hour overnight fast and 30 minutes after the start of the standard high-fat breakfast and followed with 240 mL ambient water. Subjects will be instructed to chew the tablet completely before swallowing. |
| Treatment D | ACTIVE_COMPARATOR | Single dose of currently marketed US 10 mg cetirizine as immediate release tablet (ZYRTEC®), administered orally after a 10-hour overnight fast and followed with 240 mL ambient water. |
| Treatment E | ACTIVE_COMPARATOR | Single dose of currently marketed EU/Australian 10 mg cetirizine film coated tablet (REACTINE®) administered orally after a 10-hour overnight fast and followed with 240 mL ambient water. |
| ODT with Water | EXPERIMENTAL | Experimental Cetirizine 10 mg Orodispersible Tablet (ODT) taken with 240 mL of water |
| ODT Without Water | EXPERIMENTAL | Experimental Cetirizine 10 mg Orodispersible Tablet (ODT) taken without 240 mL of water |
| FCT with Water | ACTIVE_COMPARATOR | Marketed Cetirizine 10 mg Film-Coated Tablet (FCT) taken with 240 mL of water |
| Name | Type | Description |
|---|---|---|
| Cetirizine 10mg | DRUG | Chewable tablet |
| Cetirizine 10 mg | DRUG | Immediate Release Tablet |
| Cetirizine | DRUG | A single 10 mg dose of an experimental Cetirizine Orodispersible Tablet (ODT), with a 7-day washout period between visits |
Inclusion Criteria: 1. Healthy male or female subject between the ages of 18 and 55 years, inclusive. Health is defined as the absence of clinically relevant abnormalities as judged by the Investigator on the basis of a detailed medical history, physical examination, blood pressure, pulse rate meas...
Cetirizine is used for allergy. It is a small molecule in the immunology therapeutic area. The clinical trials listed for Cetirizine enrolled adults with allergy, and both studies were conducted in Canada. Cetirizine is also known as Cetirizine 10mg.
Cetirizine targets HRH1, the histamine H1 receptor, and acts as an antagonist at this receptor. By blocking HRH1, Cetirizine interferes with histamine signaling, which is relevant to its use in allergy. The target class for Cetirizine is antagonist.
Cetirizine is developed by Johnson & Johnson, which trades under the ticker JNJ. Johnson & Johnson is the company associated with the clinical development of Cetirizine in the trials listed for this asset.
Cetirizine is in Phase 1 clinical development. It is investigational and has not been shown to be approved. The available trial record includes two Phase 1 studies, one completed and one completed, with no active trials currently listed.
Cetirizine has been studied in two Phase 1 trials: NCT03772158, a chewable bioequivalence and food effect study with 40 participants, and NCT01322282, a bioequivalence study of two tablet formulations with 36 participants. Both were completed in Canada and enrolled healthy adult volunteers.