Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Levocetirizine IRT · 1 trial · 1 indication
Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin).
Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin).
Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data.
Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data.
| Arm | Type | Description |
|---|---|---|
| Subjects of Group A: Part 1 | EXPERIMENTAL | Subjects in Group A will be randomized to receive levocetirizine IRT 5 mg with 150 mL water in fasted state in Period 1. After a washout period of at least 5 days, subjects will receive levocetirizine ODT 5 mg with 150 mL water in fasted state in Period 2. |
| Subjects of Group B: Part 1 | EXPERIMENTAL | Subjects in Group B will be randomized to receive levocetirizine ODT 5 mg with 150 mL water in fasted state in Period 1. After a washout period of at least 5 days, subjects will receive levocetirizine IRT 5 mg with 150 mL water in fasted state in Period 2. |
| Subjects of Group C: Part 2 | EXPERIMENTAL | Subjects in Group C will be randomized to receive levocetirizine IRT 5 mg with 150 mL water in fasted state in Period 1. After a washout period of at least 5 days, subjects will receive levocetirizine ODT 5 mg without water in fasted state in Period 2. |
| Subjects of Group D: Part 2 | EXPERIMENTAL | Subjects in Group D will be randomized to receive levocetirizine ODT 5 mg without water in fasted state in Period 1. After a washout period of at least 5 days, subjects will receive levocetirizine IRT 5 mg with 150 mL water in fasted state in Period 2. |
| Name | Type | Description |
|---|---|---|
| Levocetirizine IRT 5 mg | DRUG | Levocetirizine IRT will be available as film-coated tablets. Subjects will receive a single dose of 5 mg levocetirizine IRT. Subjects will receive levocetirizine IRT with 150 mL water in both Part (1 and 2). |
| Levocetirizine ODT 5 mg | DRUG | Levocetirizine ODT will be available as oral disintegrating tablet. Subjects will receive a single dose of 5 mg levocetirizine ODT. In Part 1, subjects will receive levocetirizine ODT with 150 mL water and in Part 2 subjects will receive levocetirizine ODT without water. |
Inclusion Criteria: * Subjects must be 20 to 55 years of age inclusive, at the time of signing the informed consent. * Japanese subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * Subjects ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150, Standard therapy for INCS |
| Polyrizon Ltd. | PLRZ | 1 | N/A | Undisclosed |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | - | Undisclosed |
Levocetirizine IRT is an investigational small molecule being developed for rhinitis. It is an immediate release tablet formulation of levocetirizine. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Levocetirizine IRT is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 1 clinical development for the treatment of rhinitis.
Levocetirizine IRT is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The drug is being studied for the treatment of rhinitis.
Levocetirizine IRT has one completed clinical trial, NCT03555890, a Phase 1 bioequivalence study comparing the oral disintegrating tablet and immediate release tablet formulations. The study enrolled 72 healthy male volunteers in Japan and was completed.
Levocetirizine IRT is the immediate release tablet formulation of levocetirizine, while Levocetirizine ODT is the oral disintegrating tablet formulation. They are different formulations of the same active ingredient, and a bioequivalence study has been conducted to compare them.