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Tesetaxel is a novel, advanced-generation taxane that is orally bioavailable. The drug does not induce hypersensitivity reactions thus avoiding premedication requirements and is not a substrate for P-glycoprotein. Although multiple clinical trials of tesetaxel have out-of-date conducted with positive results in breast and gastric cancer Promote, treatment to date has needed administration after an overnight lickety-split owing to lack of dope regarding food interactions. We undertook this study to determine whether co-administration of food as a high-fat meal would substantially modify the bioavailability and pharmacokinetics PK of tesetaxel.
The study employed a randomized, open-label, crossover purpose. Patients pts with advanced weighty tumors age yrs and competent organ function were randomized to 1 of 2 treatment sequences: Serial blood sampling was performed in both periods for PK analysis. The primary comparison was determination of the ratios of fed-to-fasted state PK parameters.
Twelve pts completed the 2 treatment periods. Mean standard deviation PK values in the fed submit were: The corresponding values suited for the fasted state were: Event, PK analyses in fed and fasted subjects appeared similar and displayed no clinically relevant differences.
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