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最高研发阶段批准上市 |
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首次获批日期1983-01-01 |
A Randomized, Placebo-Controlled, Double-Blind, Double Dummy Trial To Determine The Relative Effect Of Pm101 Versus Placebo And Amiodarone IV On Blood Pressure In Subjects With Stable Congestive Heart Failure
The primary objective of this trial is to compare the relative hemodynamic effect of a novel intravenous formulation of amiodarone (PM101), administered as an immediate IV bolus push, with placebo and with the currentlyl available formulation of Amiodarone IV, administered as a 10-minute IV infusion, on systolic arterial pressure.
A Randomized, Double-blind, Double-dummy, Placebo-controlled Trial to Determine the Relative Effect of PM101 I.V. Versus Placebo on Hemodynamics in Healthy Adult Volunteers
The primary objective of the study is to compare the effect of PM101 I.V. administered as an immediate intravenous bolus versus placebo on systolic blood pressure. Secondary objectives include evaluation of change from baseline in heart rate and change from baseline to the lowest value in mean arterial pressure and diastolic pressure.
A Randomized, Double-blind, 2-period Crossover Trial to Determine the Relative Bioavailability of PM101 I.V. (Amiodarone HCl) and Cordarone I.V. in Healthy Adult Volunteers
Determine the relative bioavailability of PM101 I.V. and Cordarone I.V.
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