6 results
Primary:To obtain paediatric pharmacokinetic data of enalapril and its active metabolite enalaprilat in paediatric patients treated with enalapril ODMTs to describe the dose exposure in the paediatric population with DCM.Secondary:1. To demonstrate…
Primary Objective: To compare the pharmacokinetics of the needlefree system with the Apo-go penject. Secondary objectives: - To assess the clinical effect of Apo-go vs. de needlefree system, using an "automated tap score" and a "Timed…
The primary objective of this pilot study is to determine the effectiveness of four treatment options for local skin reactions induced by continuous subcutaneous apomorphine infusion, as compared to no treatment.The primary endpoint is the measured…
Primary:To demonstrate the safety of enalapril Orodispersible Minitablets (ODMTs).Secondary:1. To describe the acceptability and palatability of enalapril ODMTs..2. To collect additional information about pharmacokinetics and pharmacodynamics of…
Primary:To obtain paediatric pharmacokinetic data of enalapril and its active metabolite enalaprilat in patients treated with enalapril ODMTs to describe the dose exposure in the paediatric population with CHD. Secondary:1. To demonstrate safety of…
The primary objective of the study as a whole (part A-C) is to assess the PK and safety of buccal apomorphine relative to registered apomorphine formulations (subcutaneous, sublingual). Secondary objectives are the characterization of the PK-AE…