3 results
Primary: to assess the bioequivalence of LH after administration of the freeze-dried (FD) Luveris formulation (Reference) versus the liquid formulation of Luveris in the pre-filled pen (Test) based on the PK parameters AUC0-t and Cmax of serum LH.…
Main:Overall survivalSecondary:Time to castration resistant prostate cancer Time to initiation of subsequent antineoplastic therapy Symptomatic skeletal event free survival (SSE-FS) Time to first symptomatic skeletal event (SSE) Time to initiation…
Primary objective:To assess pharmacokinetic similarity of EBR/GZR as a crushed (test) Zepatier tablet compared to a whole (reference) tablet.Secondary objective:To assess Cmax similarity of EBR/GZR as a crushed (test) Zepatier tablet compared to a…