13 results
The purpose of this trial is: • to study the effect of a single dose of GAL-054 (the test medication) in healthy volunteers on the functioning of the body, especially on respiration, and compare this with the effect of a single dose of doxapram.• to…
The purpose of this study is testing a respiratory stimulant, doxapram. Painkillers such as morphine and alfentanil mute breathing. This is often undesirable, especially in patients. To counteract this attenuation is often used drugs also take away…
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…
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…
Primary Objective:* To compare event-free survival (EFS) between AG-120 + azacitidine and placebo + azacitidine. Key Secondary Objectives:* To compare the complete remission (CR) rate between AG-120 + azacitidine and placebo + azacitidine. EFS is…
The primary objective of this study is to:• Determine the safety and tolerability of AG-120 and AG-221 when administered with induction and consolidation therapy in patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate…
The main objective of our trial is to investigate if doxapram is safe and effective in reducing the composite outcome of death and neurodevelopmental impairment/severe disability at 2 years corrected age as compared to placebo.
Phase 1b Dose-finding Stage Primary Objectives· To assess the safety and tolerability of the combination treatments of oral AG-120 when administered with subcutaneous (SC) azacitidine and oral AG-221 when administered with SC azacitidine in subjects…
To assess efficacy and safety of ivosidenib/enasidenib vs. placebo in combination with induction therapy and consolidation therapy followed by maintenance therapy in patients with newly diagnosed acute myeloid leukemia (AML) or myelodysplastic…