Win 40680 (Amrinone) の臨床第1相試験-1回静注法-

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A phase I study of Win 40680 Amrinone, 5-amino-3, 4'-bipyridin-6 (1H)-one, a new non-glycosidic and non-adrenergic cardiotonic agent, by intravenous bolus injection was carried out on 12 healthy Japanese volunteers to examine the drug's safety, pharmacodynamics and pharmacokinetics.<BR>Subjective complaints, objective findings, and laboratory data were collected before and after intravenous administration of Win 40680 at doses of 0.25mg/kg, 0.50mg/1.0mg/kg and 2.0 mg/kg.<BR>Burning pain at the injection site was noticed at high doses (high concentrations), but eliminated by lowering the concentration. Facial flushing, dizziness, and nausea also appeared in some subjects, but these effects were transient and mild and rapidly disappeared spontaneously.<BR>Elevation of systolic blood pressure, reduction of diastolic blood pressure, and increase in heart rate were noted just after bolus injection and each change returned to the baseline in approximately one or two hours. Continuous ECG recording for 12 hours following the bolus injection revealed no arrhythmia. No serious side effects attributable to the drug such as thrombocytopenia or liver function disturbance were observed in hematological, blood biochemical and coagulation examinations or urinalysis except for transient lowering of the level of serum potassium and inhibition of platelet aggregation.<BR>It was concluded that Win 40680 (Amrinone) could be administered intravenously quite safely without serious side effects except for influence to serum potassium level and platelet aggregation and would be applicable to the clinical stage.
一般社団法人日本臨床薬理学会の論文

Win 40680 (Amrinone) の臨床第1相試験-1回静注法-

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