6 results
primary • To determinne the safety and tolerability of sorafenib when administered in combination with gemcitabine and carboplatin.• To determine the maximal tolerated dose (MTD), dose limiting toxicity (DLT) and optimal treatment schedule of…
The primary objective of this study is to assess the objective response rate (ORR, the percentage of treated patients in whom the tumor significantly reduces in size or becomes non-detectable) of SAR240550 administered as a 60min intravenous…
Primary objectives are:1) To evaluate the efficacy of Xyrem (sodium oxybate) oral solution in the treatment of cataplexy in pediatric subjects with narcolepsy2) To evaluate the safety of Xyrem in the treatment of cataplexy in pediatric subjects with…
Primary Objectives:Part 1:To assess the relative bioavailability and bioequivalence of JZP-258 compared with Xyrem oral solution under fasting and fed conditions.To evaluate the pharmacokinetics (PK) of JZP-258 under fasting and fed conditions (food…
The purpose of the study is to investigate how much JZP-258 is absorbed into the body, how fast JZP-258 is absorbed and eliminated from the body (this is called pharmacokinetics) compared to Xyrem. This comparison is called the relative…
During the study, the 4 KEY-507 oral solutions (KEY-507-A, KEY-507-G, KEY-507-C, and KEY 507-D) will be investigated and compared to Xyrem. The purpose of the study is to investigate how quickly and to what extent KEY-507 oral solutions are absorbed…