[Translation] Single center, randomized, open, three preparations, single administration, two cycles, double crossover fasting/postprandial pharmacokinetics study protocol of levamlodipine 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/2.5mg(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:2.5mg,持证商:Merck Healthcare Germany GmbH,商品名:Concor®)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给药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 purpose: Taking pharmacokinetic parameters as the main endpoint evaluation index, compare the single oral administration of test preparation T levoamlodipine bisoprolol tablet (specification: 2.5mg/2.5mg (based on left) Amlodipine/bisoprolol fumarate), manufacturer: Shihuida Pharmaceutical Group (Jilin) Co., Ltd.) and the comparison preparation R1 levamlodipine besylate tablets (specification: 2.5mg (calculated as levamlodipine) ), licensee: Shihuida Pharmaceutical Group (Jilin) Co., Ltd., trade name: Shihuida®), R2 bisoprolol fumarate tablets (specification: 2.5mg, licensee: Merck Healthcare Germany GmbH, trade name: Concor ®) combined administration of pharmacokinetics in healthy subjects, in order to verify the compound preparation levamlodipine bisoprolol tablet administration and single drug levamlodipine besylate tablet, bisoprolol fumarate Whether the tablet combination drug is absorbed in healthy subjects at a consistent rate and extent. Secondary purpose: To observe the safety of a single oral administration of test preparation T levoamlodipine bisoprolol tablets in healthy subjects.