4 results
Primary objectives:The primary objectives of this trial are:• To show PK similarity of BI 695500 to MabThera® and Rituxan® and of Rituxan® to MabThera® (three-way PK similarity).• To establish statistical equivalence of efficacy of BI 695500 and…
The primary objective of this study is to evaluate the safety and performance of the Permaseal device for left ventricular transapical access and closure and to gain data that will lead to CE-Mark approval for the Permaseal device.
The study will be performed in 2 parts, Parts 1 and 2. The volunteers can only participate in one of the two parts of this study. The purpose of Part 1 of the study is to investigate to what extent RO6806127 is tolerated. It will also be…
Primary Objective: To investigate the effect on the distention of the ONSD while using lidocaine 1,5 mg/kg IV during endotracheal intubation versus placebo. Secondary Objectives: The secondary objective of this study is to investigate the effect…