9 results
Primary: to assess the bioequivalence of LH after administration of the freeze-dried (FD) Luveris formulation (Reference) versus the liquid formulation of Luveris in the pre-filled pen (Test) based on the PK parameters AUC0-t and Cmax of serum LH.…
The main purpose of the study is to investigate whether the transdermal patch system HP-3070 shows blood concentrations of asenapine that make this route of administration suitable for clinical use. The transdermal route of administration is likely…
The purpose of the study is to compare the hemodynamic effects (study of blood flow or circulation, such as blood pressure, heart rate, cardiac output (the volume of blood being pumped by the heart) and glomerular filtration rate (flow rate of…
Primary ObjectivesTo quantify BCT197, and to identify and quantify its metabolites in plasma, urine, and feces.To determine the pharmacokinetics of total 14C-radioactivity in blood and plasma, and of any important metabolites in plasma and excreta.…
The purpose of the study is to evaluate the adhesiveness of two different patch formulations of rotigotine. This study is not intended to improve the health, but is necessary for the further development of the rotigotine patches
Part 1:The purpose of this study is to determine whether LMTM inhibits monoamine oxidase (MAO). MAO is an enzyme (protein involved in reactions in the body) which breaks down tyramine. By giving participants tyramine which raises the blood pressure…
Primary objective: To establish the PK profile after multiple SC administrations of tralokinumab in children with moderate-to-severe AD.Secondairy objectives: - To assess the safety and tolerability of multiple SC administrations of tralokinumab in…
• To evaluate the efficacy of VX-147 to reduce proteinuria• To evaluate the efficacy of VX 147 on renal function as measured by eGFR slope
Primary objective: To evaluate the clinical improvement of efgartigimod PH20 SC treatment compared with placebo, in addition to standard of care immunomodulatory therapy.Key secondary objectives:• To evaluate additional measures of the efficacy of…