2 results
Approved WMOCompleted
To evaluate the inter- and intra-subject variability in pharmacokinetics (PK) and pharmacodynamics (PD) of study drug following a two-period repeated single dose of 2 mg delivered by subcutaneous (SC) injection in healthy volunteers.
Approved WMOCompleted
Primary Objective:To compare the Cross Clamp Time collected with EDWARDS INTUITY Elite to published data with a conventional valve within a MIS approachSecondary Objectives:To describe short term (30 days) and long term (6 months) clinical safetyTo…