8 results
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…
The purpose of this study is to assess the anti-inflammatory effects of Indacaterol/glycopyrronium/Mometasone (QVM) 150/50/80 µg once daily versus Indacaterol/Mometasone (QMF) 150/160 µg once daily on the allergen-induced late asthmatic response in…
The objective of this explorative study is to determine the feasibility of measuring dEMG with a belt in preterm and term born infants during routine caregiving. Feasibility is confirmed when heart rate and respiratory rate reach a predefined level…
To establish equivalence (non-inferiority) between monitoring performance of the Bambi Belt and the currently used cardio-respiratory monitoring device. The Bambi Belt is a potentially more patient friendly, wireless cardio-respiratory monitoring…
We aim to investigate whether sodium oxybate can be used as a novel treatment in psychiatric patients with catatonia. Our primary objective is: To determine if sodium oxybate is effective as a novel treatment in psychiatric patients with catatonia…
Demonstrate the suitability of cardiorespiratory monitoring directly after birth using a novel, wireless, non-adhesive device.
To evaluate the efficacy of sodium oxybate (SXB) as a medical intervention to treat disrupted night sleep in the ICU.