15 results
The purpose of this study is to evaluate the single dose pharmacokinetics and pivotal bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed dose…
Primary ObjectiveTo evaluate the effect of a single 84-mg dose of intranasal esketamine compared to placebo, on next day driving performance and repeated administration of 84 mg intranasal esketamine on same-day driving performance as assessed by…
To evaluate the effect of intranasal esketamine 84 mg on cognition, and duration of cognitive effects (if present), as assessed using a computerized test battery (Cogstate®).
Primary Objective:In this pilot study, the authors aim is to investigate whether esketamine reduces the incidence of POD in elderly patientspresenting for noncardiac surgery.Secondary Objective(s):To examine whether esketamine has an effect on the…
Part 1:The purpose of Part 1 of the study is to investigate how much of the OZ439 compound is absorbed into, distributed in, and eliminated from the body (this is called pharmacokinetics) when administered orally as compared to an intravenous (iv;…
The aim of this study is to demonstrate that procedural sedation with propofol and esketamine is more effective and will result in less cardiopulmonary depression than sedation with propofol and the opioid alfentanil. Less side effects should also…
The aim of this study is to investigate the use of cobicistat to reduce the required dose and dose frequency of tofacitinib in the treatment of RA.
The primary objective is to demonstrate non-inferiority of experimental esketamine administration of 6x 1 day per 2 weeks (in total 3 months) as compared with standard esketamine administration of 1x 6 consecutive days. The end of study is at 6…
- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…
Objective 1: To determine the effects of S-ketamine on brain activation in healthy women, healthy women prone to depression and fibromyalgia patients.Objective 2: To determine the effects of S-ketamine on mood and other depression-related behavioral…
This is a mechanistic exploratory study. The objective of this study is to determine the effects of PulseCath® iVAC2L on ventricular loading conditions and assess impact on specific load and flow dependent humoral factors as well as cardiac enzymes…
Primary objective:The primary objective of this study is to evaluate the efficacy of flexibly dosed esketamine nasal spray compared with quetiapine extended-release(XR), both in combination with a continuing selective serotonin reuptake inhibitor (…
Part APrimary objective1. To determine the equivalence of the Area-Under-the-Curve (AUC) of the reduced, boosted dose of olaparib and the regular dose.Secondary objectives1. To determine whether boosting reduces the inter- and intrapatient PK…
Primary Objectives* To investigate the effects of PO and IV S-ketamine and its metabolite S-norketamine on functional CNS tests up to 6h (acute effects) and 24h (delayed effects) after administration using NeuroCart test battery in healthy subjects…
The main objective of this study is to evaluate if systemic exposure of osimertinib (i.e. AUC) is enhanced when osimertinib is co-administered with cobicistat in patients with relatively low blood concentrations while receiving the standard…