口服不同剂量甲磺酸酚妥拉明分散片后健康男性自愿者的耐受性和安全性研究

目的　为了解口服甲磺酸酚妥拉明的人体耐受性以及可能发生的不良反应 ,本研究对 2 2名健康成年中国男性自愿者进行了随机、开放的临床试验。方法　自愿者共分 4组 ,分别按递增剂量口服 2 0、4 0、6 0、80mg单剂量 ,其中 6 0mg组为多剂量 ,每天 1次 ,连续口服 7d。结果　该药物的主要不良反应为鼻塞 (72 7% )、心悸(45 4 % )、面色潮红 (13 6 % )及头晕 (4 5 % )等 ,但程度均较轻 ,持续时间大多为 4 0min～ 2 5h之间。此外 ,在给药后 3h内 ,部分自愿者出现心率轻度加快、血压轻度改变、包括收缩压和舒张压的轻度减低 ,均以最大剂量 80mg组为明显 ,血生化、血尿常规各指标变化均在正常范围内。结论　在本试验剂量范围内的 2 2名男性健康自愿者口服甲磺酸酚妥拉明分散片是安全的 ,其对受试者所产生的副作用比较轻微 ,可以耐受

Single-dose and multiple-dose phase-l tolerance and safety study on phentolamine mesylate dispersing tablets in Chinese healthy male subjects

Objective In order to investigate the tolerance and potential adverse events of phentolamine mesylate dispersing tablets after oral administration,an open label,randomized clinical trial was conducted enrolling 22 Chinese normal male subjects.Methods All subjects were divided into 4 groups,and dose ranging was from 20 mg to 80 mg for each group.A multiple dose of 60 mg daily was applied for 6 subjects for 7 days.Results All doses of phentolamine mesylate were well tolerated,no subjects were withdrawn from the study for any reason.Adverse events were mild,and lasted for 40 min to 2 5 h including stuffy nose (72 7%),palpitation (45 4%),face flushing (13 6%) and dizzyiness (4 5%).Additionally,there was a trend to small decrease in blood pressure and increase in heart rate over 3 h post the dose.Conclusion No significant change was found in ECG and laboratory examination covering hematological test and biochemical test as well as urine test.