[Translation] Bioequivalence trial of ezetimibe and atorvastatin calcium tablets
主要目的:在健康受试者体内,在空腹和餐后条件下, 以 Organon Healthcare GmbH 持证、Merck Sharp & Dohme B.V.生产的依折麦布阿托伐他汀钙片(商品名:Atozet®,规格:10mg/20mg)为参比制剂,研究乐普制药科技有限公司研制的依折麦布阿托伐他汀钙片(规格:10mg/20mg)的药代动力学,评价受试制剂与参比制剂是否具有生物等效性。
次要目的:观察健康受试者口服受试制剂、参比制剂的安全性。
[Translation] Main purpose: In healthy subjects, under fasting and postprandial conditions, ezetimibe and atorvastatin calcium tablets (trade name: Atozet®, specifications) produced by Organon Healthcare GmbH and licensed by Merck Sharp & Dohme B.V. : 10mg/20mg) as the reference preparation, study the pharmacokinetics of ezetimibe and atorvastatin calcium tablets (specification: 10mg/20mg) developed by Lepu Pharmaceutical Technology Co., Ltd., and evaluate the test preparation and reference preparation. Whether it is bioequivalent.
Secondary purpose: To observe the safety of oral administration of the test preparation and reference preparation to healthy subjects.
[Translation] Fasting Bioequivalence Test of Epalrestat Tablets
主要目的:健康受试者在空腹条件下,以Ono Pharmaceutical Co., Ltd/アルフレッサファーマ株式会社(Alfresa Pharma Corporation)持有的依帕司他片(商品名:Kinedak;规格:50 mg)为参比制剂,研究乐普制药科技有限公司研制的依帕司他片(规格:50 mg)的药代动力学,评价受试制剂与参比制剂是否具有生物等效性。
次要目的:观察健康受试者空腹口服受试制剂、参比制剂的安全性。
[Translation] Main purpose: Under fasting conditions, healthy subjects were treated with epalrestat tablets (trade name: Kinedak; specification: 50 mg) held by Ono Pharmaceutical Co., Ltd/Alfresa Pharma Corporation. To compare preparations, study the pharmacokinetics of epalrestat tablets (specification: 50 mg) developed by Lepu Pharmaceutical Technology Co., Ltd., and evaluate whether the test preparation and the reference preparation have bioequivalence.
Secondary purpose: To observe the safety of healthy subjects taking the test preparation and the reference preparation orally on an empty stomach.
[Translation] Bioequivalence Test of Ezetimibupitavastatin Calcium Tablets
主要目的:在健康受试者体内,在空腹条件下以乐普制药科技有限公司生产的依折麦布匹伐他汀钙片(规格:10mg/2mg)为试验药物,以MSD Pharma(Singapore)Pte. Ltd.持证原研进口的依折麦布片(商品名:益适纯®;规格:10mg)及 Kowa Company, Ltd. 持证原研进口匹伐他汀钙片(商品名:力清之®;规格 2mg)为参照药物,研究健康受试者口服试验药物、参照药物后的药代动力学特征,评价试验药物与参照药物是否具有生物等效性。
次要目的:观察健康受试者口服试验药物、参照药物的安全性及耐受性。
[Translation] Main purpose: In healthy subjects, under fasting conditions, ezetimibe, pitavastatin calcium tablets (specification: 10mg/2mg) produced by Lepu Pharmaceutical Technology Co., Ltd. was used as the test drug, and MSD Pharma (Singapore) Pte. Ltd. licensed original research and imported ezetimibe tablets (trade name: Yishichun®; specification: 10mg) and Kowa Company, Ltd. licensed original research and imported pitavastatin calcium tablets (trade name: Liqingzhi®; specification 2 mg) as the reference drug, study the pharmacokinetic characteristics of healthy subjects after oral administration of the test drug and the reference drug, and evaluate whether the test drug and the reference drug are bioequivalent.
Secondary objective: To observe the safety and tolerability of oral test drug and reference drug in healthy subjects.
100 Clinical Results associated with Lepu Pharmaceutical Technology Co., Ltd.
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