8 results
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…
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 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…
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…
Demonstrate the suitability of cardiorespiratory monitoring directly after birth using a novel, wireless, non-adhesive device.
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…
To evaluate the efficacy of sodium oxybate (SXB) as a medical intervention to treat disrupted night sleep in the ICU.