中国健康男性志愿者单次口服甲磺酸酚妥拉明片耐受性研究

目的 在中国男性健康志愿者中评价单次口服Ⅳ+Ⅴ类新药甲磺酸酚妥拉明片的安全性、耐受性。 方法 根据新药临床试验指导原则设计试验方案, 按照赫尔辛基宣言和GCP 指导原则, 选择18 ~50 岁健康成人, 用区组随机化设计方法, 按随机表将36 名受试者随机分配至10、20、30、40、50 和60mg剂量组, 每组6 名受试者。观察指标为临床症状、生命体征、心电图、血常规、尿常规、肝功能、肾功能、电解质等。 结果 单次口服10 ~ 60mg 甲磺酸酚妥拉明片, 志愿者体温、脉搏、呼吸频率、卧立位血压、心电图、血常规、肝功能、肾功能、电解质等各项指标测定值均在正常范围内, 仅见面部潮红、鼻塞、头晕头痛或脉率增快(20 例) 等与药物可能有关的一过性轻微不良反应。9 例志愿者在给药后20 ~ 30 min 后发生阴茎勃起现象, 约持续5 min 左右。 结论 36 名中国男性健康受试者单次口服甲磺酸酚妥拉明片最大剂量至60 mg 比较安全、耐受性较好。

Investigation of tolerance to a single oral dose of phentolamine mesylate in Chinese healthy male volunteers

AIM: To investigate the safety and tolerance of phentolamine mesylate in Chinese healthy male volunteers. METHODS: The trial protocol was designed according to the Good Clinical Practice (GCP) of the State Drug Administration of China (SDA).Thirty-six healthy volunteers in 18 -50 years old were chosen and randomized to 6 dose groups, including 10, 20, 30, 40, 50 and 60mg (n =6).Some indices were examined, including clinical symptoms, vital signs, routine blood tests, routine urine tests, hepatic functions, renal functions, blood electrolytes, electrocardiogram, and electroencephalogram. RESULTS: After single oral doses of 10 -60 mg, the vital signs, the clinical symptoms, and the values of laboratory tests were in the normal range. However, some slight adverse reactions were related to the drug, such as face flushing, nosal obstruction, dizziness, and pulse increased after administration.Penile erection was found in 9 volunteers 20 -30 min after administration. CONCLUSION: The single dose of 60 mg domestic phentolamine mesylate was safe and tolerable in 36 Chinese healthy male volunteers.