drugset / Trial / NCT04592198

Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting

NCT04592198

Phase 2 Completed 22 enrolled Xiamen LP Pharmaceutical Co., Ltd
RandomizedParallel-groupOpen-labelPrevention

Summary

Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film delivery compared to iv injection for chemotherapy induced nausea or vomiting (CINV). Subjects receive a single dose of palonosetron prior to moderately emetogenic chemotherapy.

Timeline

Start
2020-10-01
Primary completion
2021-03-25
Completion
2021-03-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Palonosetron Other / unclassified 0.25 mg Other
Subject Palonosetron Other / unclassified 0.5 mg Other