4 results
1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…
Primary objectives:To characterize the pharmacokinetics of the 300 mg trientine capsule with a fast dissolution profile.To assess the effect of dissolution rate on the pharmacokinetics of trientine.To assess the effect of food on the…
The primary objective of this study is to evaluate and compare the plasma PK parameters of TETA and its two metabolites (MAT and DAT) after two dose levels of Syprine® capsules and TETA 4HCL tablets in adult healthy male and female volunteers.The…
The objective of this First-in-Human (FIH) evaluation is to assess the safety and performance of transcatheter based mitral repair in subjects with mitral regurgitation.