一项单中心、开放、单臂研究评估在中国成年健康志愿者中氟伏沙明和利福平对琥珀八氢氨吖啶片的药物-药物相互作用
[Translation] A single-center, open-label, single-arm study evaluating the drug-drug interactions of fluvoxamine and rifampicin on succinylcholine tablets in healthy adult Chinese volunteers
主要目的:
(1)评价琥珀八氢氨吖啶片单独使用和与氟伏沙明合用时在中国成年健康受试者中的药代动力学特征;
(2)评价琥珀八氢氨吖啶片单独使用和与利福平合用时在中国成年健康受试者中的药代动力学特征。
次要目的:
(1)评价琥珀八氢氨吖啶片单独使用和与氟伏沙明合用时在中国成年健康受试者中的安全性和耐受性特征;
(2)评价琥珀八氢氨吖啶片单独使用和与利福平合用时在中国成年健康受试者中的安全性和耐受性特征。
[Translation] Primary objectives:
(1) To evaluate the pharmacokinetic characteristics of succinic acid tablets when used alone and in combination with fluvoxamine in healthy adult Chinese subjects;
(2) To evaluate the pharmacokinetic characteristics of succinic acid tablets when used alone and in combination with rifampicin in healthy adult Chinese subjects.
Secondary objectives:
(1) To evaluate the safety and tolerability characteristics of succinic acid tablets when used alone and in combination with fluvoxamine in healthy adult Chinese subjects;
(2) To evaluate the safety and tolerability characteristics of succinic acid tablets when used alone and in combination with rifampicin in healthy adult Chinese subjects.
[14C]琥珀八氢氨吖啶在中国成年男性健康志愿者体内吸收、代谢和排泄临床试验——[14C]琥珀八氢氨吖啶人体物质平衡与生物转化研究临床试验
[Translation] Clinical trial on the absorption, metabolism and excretion of [14C] succinic octahydroaminoacridine in healthy adult male volunteers in China——Clinical trial on the material balance and biotransformation of [14C] succinic octahydroaminoacridine in humans
主要目的:
评价中国男性健康志愿者单次口服[14C]琥珀八氢氨吖啶的物质平衡及生物转化途径。
次要目的:
评价琥珀八氢氨吖啶在人体内的药代动力学整体特征及安全性。
[Translation] Primary objective:
To evaluate the material balance and biotransformation pathway of [14C] succinic acid octahydrogenacridine after a single oral administration in healthy Chinese male volunteers.
Secondary objective:
To evaluate the overall pharmacokinetic characteristics and safety of succinic acid octahydrogenacridine in humans.
单中心、随机、双盲、安慰剂对照的评估健康成人单次口服琥珀八氢氨吖啶片4 mg及12 mg对QT间期延长的影响
[Translation] A single-center, randomized, double-blind, placebo-controlled study evaluating the effects of a single oral dose of 4 mg and 12 mg succinylcholine on QT interval prolongation in healthy adults
主要目的:评估中国成年健康志愿者单次口服琥珀八氢氨吖啶片4 mg及12 mg对QT间期延长的影响。 次要目的:评估单次口服琥珀八氢氨吖啶片4 mg及12 mg情况下,血药浓度与QTc间期变化的关系;药代动力学(PK)特征;受试者的耐受性;如有主要代谢产物将评价其对QT间期延长的影响。
[Translation] Primary objective: To evaluate the effect of a single oral administration of 4 mg and 12 mg of succinic acid tablets on QTc prolongation in healthy adult Chinese volunteers. Secondary objectives: To evaluate the relationship between blood drug concentration and QTc interval changes after a single oral administration of 4 mg and 12 mg of succinic acid tablets; pharmacokinetic (PK) characteristics; tolerability of subjects; if there are major metabolites, their effects on QTc prolongation will be evaluated.
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