[Translation] A single-center, randomized, open-label, three-dose, single-dose, two-period, double-crossover fasting/postprandial pharmacokinetic study of levoamlodipine-bisoprolol tablets in healthy subjects
主要目的:以药代动力学参数作为主要终点评价指标,分别比较在空腹/餐后状态下单次口服受试制剂T左氨氯地平比索洛尔片(规格:2.5mg/5mg(以左氨氯地平/富马酸比索洛尔计),生产厂家:施慧达药业集团(吉林)有限公司)与对照制剂R1苯磺酸左氨氯地平片(规格:2.5mg(以左氨氯地平计),持证商:施慧达药业集团(吉林)有限公司,商品名:施慧达®)、R2富马酸比索洛尔片(规格:5mg,持证商:默克制药(江苏)有限公司,商品名:康忻®)联合给药在健康受试者体内的药代动力学行为,以验证复方制剂左氨氯地平比索洛尔片与单药苯磺酸左氨氯地平片、富马酸比索洛尔片联合用药在健康受试者体内吸收速度和程度是否一致。次要目的:观察单次口服受试制剂T左氨氯地平比索洛尔片在健康受试者中的安全性。
[Translation] Main objective: To compare the pharmacokinetic parameters as the primary endpoint evaluation indicators, and to compare the pharmacokinetic behavior of the test preparation T levamlodipine bisoprolol tablets (specification: 2.5mg/5mg (calculated as levamlodipine/bisoprolol fumarate), manufacturer: Shi Huida Pharmaceutical Group (Jilin) Co., Ltd.) and the control preparations R1 levamlodipine besylate tablets (specification: 2.5mg (calculated as levamlodipine), license holder: Shi Huida Pharmaceutical Group (Jilin) Co., Ltd., trade name: Shi Huida®) and R2 bisoprolol fumarate tablets (specification: 5mg, license holder: Merck Pharmaceuticals (Jiangsu) Co., Ltd., trade name: Kangxin®) in healthy subjects after a single oral administration in the fasting/postprandial state, so as to verify whether the absorption rate and extent of the combination preparation levamlodipine bisoprolol tablets and the single drug levamlodipine besylate tablets and bisoprolol fumarate tablets are consistent in healthy subjects. Secondary objective: To observe the safety of a single oral administration of the test formulation T levamlodipine bisoprolol tablets in healthy subjects.