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研究对象为23名健康男性,分成四组,每组中各4例分别口服纳美芬(Nalmefene)盐酸盐胶囊50、100、200或300mg;其余则口服安慰剂。其中6例以后口服本品20mg,每12小时1次,共7日。口服本品单剂或多剂,耐受良好。仅当剂量100～300mg时有一过性头昏。血浆浓度-时间曲线说明,本品吸收迅速,1～3小时达血浆浓度峰值,半衰期6.5～15.1小时(平均10.7小时)。峰浓度与剂量相关(r=0.94)。仅4%左右以原形由尿排出;60%以本品β-葡萄糖醛酸酶/硫酸酯酶结合物形式
The study population consisted of 23 healthy men, divided into four groups, each with 4 oral nalmefene hydrochloride capsules 50, 100, 200 or 300 mg, and the rest orally with placebo. After 6 cases of oral administration of this product 20mg, every 12 hours 1, a total of 7 days. Oral this product single or multiple doses, well-tolerated. Only when the dose of 100 ~ 300mg transient transient dizziness. Plasma concentration - time curve shows that the rapid absorption of this product, 1 to 3 hours peak plasma concentration, half-life of 6.5 to 15.1 hours (an average of 10.7 hours). Peak concentration was dose-related (r = 0.94). Only about 4% of the prototype by urine; 60% of the goods β-glucuronidase / sulfatase conjugate form