Target- |
Mechanism- |
|
|
|
Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
[Translation] Human bioequivalence test of meglumine meglumine soft capsules
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] Main purpose: In healthy subjects, under fasting and postprandial conditions, clofenzoate dimeglumine soft capsules (trade name: Vyndaqel®; strength: 20 mg (according to C14H7Cl2NO3. (calculated as C7H17NO5)) is the reference preparation, and the meglumine soft capsule (specification: 20 mg (calculated as C14H7Cl2NO3.C7H17NO5)) produced by Shijiazhuang Keren Pharmaceutical Technology Co., Ltd. is the test preparation. The pharmacokinetics of the two preparations are studied. Kinetics to evaluate whether the two preparations are bioequivalent.
Secondary purpose: To observe the safety of test preparation and reference preparation in healthy subjects.
[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] Main purpose: In healthy subjects, under fasting conditions, use Lercanidipine Hydrochloride Tablets (trade name: Zanidip®; Specification: 10 mg) held by Recordati S.P.A. as the control drug to study the drug developed by Shijiazhuang Keren Pharmaceutical Technology Co., Ltd. The human pharmacokinetics of RHYK2008 (specification: 10 mg; experimental drug) will provide a basis for subsequent clinical trials.
Secondary purpose: To observe the safety of healthy subjects taking the test drug and control drug orally on an empty stomach.
100 Clinical Results associated with Shijiazhuang Keren Medical Technology Co., Ltd.
0 Patents (Medical) associated with Shijiazhuang Keren Medical Technology Co., Ltd.
100 Deals associated with Shijiazhuang Keren Medical Technology Co., Ltd.
100 Translational Medicine associated with Shijiazhuang Keren Medical Technology Co., Ltd.