23 results
To compare midazolam pharmacokinetics in morbidly obese patients before/during bariatric surgery and 0.5-2 year after surgery.
To determine the influence of OATP1B inhibition, through rifampicin exposure, on the metabolism and plasma pharmacokinetics of sorafenib and its metabolites.
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 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…
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…
The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…
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…
The hypothesis is that a switch from intravenous to oral antimicrobial therapy is non-inferior to standard intravenous therapy in patients with low-risk SAB. Therefore, the primary objective of the trial is to demonstrate, that oral switch therapy (…
Primary objectiveTo evaluate if tralokinumab after 14 weeks of treatment (at steady state) changes the metabolism of substrates of CYP 1A2, 2C9, 2C19, 2D6, or 3A4 pathways in subjects with moderate-tosevere atopic dermatitisSecondary objectivesTo…
The study will be performed in 3 parts, Parts 1, 2 and 3. In all parts, the purpose is to investigate to what extent APX001 is tolerated. In addition, it will be investigated how quickly and to what extent APX001 is absorbed and eliminated from the…
- 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…
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…
• 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…
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…
In this study we will investigate how quickly and to what extend the approved compounds repaglinide, tolbutamide, midazolam or caffeine are absorbed and eliminated from the body when it is given together with PXL770. This study is a drug-drug…
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…
Primary objective:• To investigate the effect of THB001 on the pharmacokinetics (PK) of caffeine, omeprazole and midazolam.Secondary objective:• To evaluate the safety and tolerability of THB001 co-administered with caffeine, omeprazole and…
The primary objective is to quantify the LIN AUC0-12h increase after addition of 250 mg, or 500 mg CLA compared to baseline (0 mg CLA). The secondary objectives are to describe the LIN and CLA pharmacokinetic parameters and to assess short-term…
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…