Delving into the Latest Updates on Zhejiang Changdian Pharmaceutical Co. Ltd. with Synapse

Overview

本试验旨在研究单次空腹和餐后口服浙江长典医药有限公司开发，并委托江苏诺泰澳赛诺生物制药股份有限公司生产的氨氯地平阿托伐他汀钙片（5 mg/10 mg）的药代动力学特征；以Pfizer Manufacturing Deutschland GmbH（Betriebsstatte Freiburg）生产，瀚晖制药有限公司进口分包装的氨氯地平阿托伐他汀钙片（多达一®，5 mg/10 mg）为参比制剂，比较两制剂中药动学参数（氨氯地平：Cmax、AUC0-72；阿托伐他汀：Cmax、AUC0-t、AUC0-∞），评价两制剂的人体生物等效性。

[Translation]

This study aimed to investigate the pharmacokinetic characteristics of a single fasting and postprandial oral amlodipine atorvastatin calcium tablet (5 mg/10 mg) developed by Zhejiang Changdian Pharmaceutical Co., Ltd. and manufactured by Jiangsu Notai Ausino Biopharmaceutical Co., Ltd.; using amlodipine atorvastatin calcium tablet (DaDaYi®, 5 mg/10 mg) produced by Pfizer Manufacturing Deutschland GmbH (Betriebsstatte Freiburg) and imported by Hanhui Pharmaceutical Co., Ltd. as the reference preparation, to compare the pharmacokinetic parameters of the two preparations (amlodipine: Cmax, AUC0-72; atorvastatin: Cmax, AUC0-t, AUC0-∞), and to evaluate the bioequivalence of the two preparations in humans.

Start Date20 Apr 2021

Sponsor / Collaborator

Zhejiang Changdian Pharmaceutical Co. Ltd.

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