10 results
Are fluconazole saliva levels representative for serum levels in children and neonates?
The objectives are:1. the effect of steady state concentrations of voriconazole and fluconazole on the steady-state pharmacokinetics of TMC125,2. the effect of steady-state concentrations of TMC125 on the steady-state pharmacokinetics of…
To evaluate the long-term safety and tolerability of ralinepag (ADP811) in subjects who participated in a preceding Phase 2 or Phase 3 study of ralinepag.
The primary objective of the study is to evaluate the safety and tolerability of the Occlutech® AFR device by assessing the incidence of SADEs in the 3 months following implantation. Secondary objectives are related to safety and efficacy:• To…
The primary objective is to determine the absorption of orally administered antibiotics in patients with SBS, to guide in clinical decision making when faced with catheter related infections.
Primary objective: To determine the effect of obesity (BMI *35 kg/m2) on the pharmacokinetics, including oral bioavailability of fluconazole.Secondary objective: To develop an optimal dosing regimen for obese patients.
Primary Objectives 1. To evaluate the pharmacokinetics of fluconazole and micafungin both administered after randomization in neonates with suspected or culture-proven Candidiasis in order to validate their optimal dosage and identify covariates…
Primary objective:• To establish an improved fluconazole dosing regimen for paediatric and adolescent patients aged 2-18 years. Exploratory objectives:• To explore the role of renal function on the clearance of fluconazole.• To explore the…
To demonstrate the effect of ralinepag on the time to first adjudicated protocol-defined clinical worsening event in subjects with PAH.
The objective of this study is to investigate whether an interatrial shunt device is superior to sham procedure in prevention of: (1) incidence of and time to cardiovascular mortality through 12-24 months; (2) incidence of and time to heart…