4 results
To develop a PKPD dexmedetomidine model, and to assess the effect of continuous auditory stimulation on dexmedetomidine pharmacodynamics.
Primary Objective- To evaluate the safety and tolerability of AP30663 in healthy malesSecondary Objectives- To evaluate the pharmacokinetic profile of AP30663.Exploratory Objectives- To evaluate the effect of AP30663 on electrocardiographical…
Primary ObjectivesTo evaluate the safety and tolerability of AP30663 in healthy males at doses up to 12mg/kgExploratory ObjectiveTo evaluate the effect of AP30663 on electrocardiographical parameters.
Objectives safety run-in: The primary objective is:• To assess the safety of i.v. teicoplanin prophylaxis three times per week with a two to three days interval in children with newly-diagnosed AML. A patient will be considered evaluable for safety…