25 results
Primary objectives:1) To evaluate the safety and tolerability of multiple doses GAL-021 in healthy volunteers.2) To evaluate the pharmacokinetic profile of multiple doses of GAL-021 in healthy volunteers.3) To evaluate the pharmacodynamic effects at…
Primary objectives:- to assess the safety and tolerability of bolus doses of ABP-700 in the presence of pre-medications commonly used in the monitored anesthesia care (MAC) setting.- to optimize bolus dosing of ABP-700 in combination with pre-…
Primary:To assess the non-inferiority of the sedative properties of continuous intravenous (i.v.) clonidine compared to continuous i.v. midazolam in mechanically ventilated children and adolescents (0 - <18 years) admitted to a paediatric…
- To assess the effects of single and multiple daily doses of 50 mg JNJ-54861911 once daily (q.d.) on the pharmacokinetics of caffeine, midazolam, and tolbutamide in healthy male subjects. - To assess the safety and tolerability of the concomitant…
The main objective of this study is to investigate which premedication scheme reduces best the pain during and after a BMAB and reduces best the fear for a possible next BMAB. Other objectives are the influence of the different medication schemes on…
The study will consist of three parts, part A, B and C. The main purpose of the study is to investigate to what extent VX-983 is safe and tolerated. In addition, it will be investigated how quickly and to what extent VX-983 is absorbed and…
The primary objective of this study is to investigate whether CYP3A phenotype, as measured with midazolam clearance, correlates with cabazitaxel clearance. Our secondary objective is to investigate whether this CYP3A phenotype outperforms BSA as a…
To determine the influence of OATP1B inhibition, through rifampicin exposure, on the metabolism and plasma pharmacokinetics of sorafenib and its metabolites.
• To determine the onset of action of IN MDZ as compared to IV MDZ.• To determine extend and duration of the sedative effects of 2.5 mg and 5 mg IN MDZ. • To estimate the absolute and relative bioavailability and dose proportionality of single doses…
Primary objective:The study has hierarchical co-primary objectives to demonstrate that:- Firstly: dexmedetomidine is at least as effective as sedation with midazolam and daily sedation stops, in maintaining a target depth of sedation in ventilated…
The aim of the present study is to investigate the differences in patient and endoscopist satisfaction and experiences and patient*s safety with different sedation protocols.
To compare midazolam pharmacokinetics in morbidly obese patients before/during bariatric surgery and 0.5-2 year after surgery.
Primary objectives:• To assess the safety and tolerability of induction doses of ABP-700 • To optimize induction dosing of ABP-700 in combination with pre-medicationsSecondary objectives:• To characterize the pharmacokinetics (PK) of ABP-700 and its…
Primary Objective* To assess the association between changes in the number of nocturnal voids and change in Nocturia Sleep Quality Scale (NSQS) total score in adult subjects with nocturia due to Nocturnal Polyuria (NP)Secondary Objectives* To assess…
Primary aim:The primary aim of this study is to evaluate the effect of two consecutive infusions of S(+)-ketamine in patients with CRPS-I on pain relief. The design of the study is prospective, randomised, double-blind and placebo-controlled.…
The primary objective of this study is to determine whether the pharmacokinetics of midazolam show circadian rhythmicity.
The purpose of this investigation is: • To examine the effect of single and multiple doses of the new drug JNJ-39393406 (the study medication) on absorption, metabolism and excretion by the body after single administration of the drug midazolam.• To…
Primary objectives:- To assess the safety and tolerability of intravenous (IV) infusion doses and infusion dosing methodologies of ABP-700 alone or in the presence of pre-medications commonly used in the monitored anesthesia care (MAC) setting.- To…
The primary objective of this study is to study the pharmacokinetic characteristics and safety of intranasal administration of midazolam in elderly volunteers.
The purpose of this study is to investigate how quickly and to what extent GS-4224 is absorbed and eliminated from the body. We study this when the study compound is administered alone and together with compounds that influence the activity of a…