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A Randomized Crossover Study to Determine the Bioequivalence of Three Consecutive Daily Doses of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel
Kinex Pharmaceuticals Inc
This is a randomised, multicenter, open-label, 2-stage study. Both stages of the study have two treatment periods and a crossover design. The primary objective of the study is to compare the bioequivalence (BE) based on the AUC0-inf of orally administered paclitaxel (Oraxol) at the estimated clinical dose to that of IV paclitaxel.