5 results
Primary objective:• Assess the pharmacokinetics (PK) of rVWF:rFVIII and rVWF, and to assess the safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding events in subjects with severe hereditary VWDSecundary objectives:• Compare the…
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.…
This study is intended to establish a dose response rate of MR30507/09 with respect to respiratory effects compared to MR30365/07, fentanyl and placebo..
The aim of the main study is to compare the effects of MR30365/07 and fentanyl on ventilation and analgesic responses to noxious electrical and heat stimulation in healthy volunteers, by performing pharmacokinetic / pharmacodynamics (PK/PD) modeling…
The primary objective of this study is to prospectively evaluate the annualized bleeding rate (ABR) for spontaneous bleeding episodes while on prophylactic treatment with rVWF (vonicog alfa) and to compare it to the subject's historical ABR for…