8 results
The primary objective of this phase III study in subjects with metastatic and/or unresectable GIST who have progressed after therapy with at least imatinib and sunitinib is to compare the treatment groups in terms of Progression-Free Survival (PFS…
Primary objective: The primary objective of the study is to determine the effect of oral dipyridamole treatment on the innate immune response induced by a lipopolysaccharide (LPS) challenge. Various pro- and anti-inflammatory cytokines will be…
Main study:1. Does blockade of the angiotensin II AT1-receptor improve the insulin-induced microvascular effects in hypertensive patients.2. Does blockade of the angiotensin II AT1-receptor impair the insulin-induced mi-crovascular effects in…
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…
The objectives of the study are to assess whether:(1) SNP will reduce the occurrence of psychomimetic side effects during exposure to low-dose ketamine;(2) SNP will reduce the ketamine-induced increase in blood pressure and cardiac output;(3) SNP is…
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…