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[Translation] Human pharmacokinetic study of RHYK2008
主要目的:在健康受试者体内,空腹条件下,以Recordati S.P.A.持有的盐酸乐卡地平片(商品名:Zanidip®;规格:10 mg)为对照药,研究石家庄科仁医药科技有限公司研发的RHYK2008(规格:10 mg;试验药)的人体药代动力学,为后续临床试验提供依据。
次要目的:观察健康受试者空腹口服试验药、对照药的安全性。
[Translation] Primary objective: To study the pharmacokinetics of RHYK2008 (specification: 10 mg; experimental drug) developed by Shijiazhuang Keren Pharmaceutical Technology Co., Ltd. in healthy subjects under fasting conditions, using Lercanidipine Hydrochloride Tablets (trade name: Zanidip®; specification: 10 mg) owned by Recordati S.P.A. as the control drug, to provide a basis for subsequent clinical trials.
Secondary objective: To observe the safety of fasting oral administration of experimental drugs and control drugs in healthy subjects.
[Translation] Bioequivalence study of clofazodone meglumine soft capsules in human body
主要目的:在健康受试者体内,分别在空腹和餐后条件下,以Pfizer Europe MA EEIG 持有的氯苯唑酸葡胺软胶囊(商品名: Vyndaqel®;规格:20 mg(按C14H7Cl2NO3.C7H17NO5 计))为参比制剂,石家庄科仁医药科技有限公司生产的氯苯唑酸葡胺软胶囊(规格:20 mg(按C14H7Cl2NO3.C7H17NO5 计))为受试制剂,研究两制剂的药代动力学,评价两制剂是否具有生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: To study the pharmacokinetics of clofazodone glucamine soft capsules (trade name: Vyndaqel®; specification: 20 mg (calculated as C14H7Cl2NO3.C7H17NO5)) held by Pfizer Europe MA EEIG as the reference preparation and clofazodone glucamine soft capsules (specification: 20 mg (calculated as C14H7Cl2NO3.C7H17NO5)) produced by Shijiazhuang Keren Pharmaceutical Technology Co., Ltd. as the test preparation in healthy subjects under fasting and postprandial conditions, and to evaluate whether the two preparations are bioequivalent.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.
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