琥珀八氢氨吖啶片治疗轻、中度阿尔茨海默病的52 周单臂、开放性、多中心临床试验
[Translation] A 52-week single-arm, open-label, multicenter clinical trial of succinate-containing octahydroacinol tablets for the treatment of mild to moderate Alzheimer's disease.
评价琥珀八氢氨吖啶片治疗轻、中度阿尔茨海默病安全性和有效性
[Translation] Evaluation of the safety and efficacy of succinate-containing octahydroacrylamide tablets in the treatment of mild to moderate Alzheimer's disease.
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.
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