[Translation] Bioequivalence study of pantoprazole sodium enteric-coated tablets in humans
本试验旨在研究单次餐后口服湖北济安堂药业股份有限公司研制、生产的泮托拉唑钠肠溶片(40 mg)的药代动力学特征;以Takeda GmbH生产的泮托拉唑钠肠溶片(潘妥洛克®,40 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] The purpose of this experiment is to study the pharmacokinetic characteristics of pantoprazole sodium enteric-coated tablets (40 mg) developed and produced by Hubei Jiantang Pharmaceutical Co., Ltd. after a single meal; pantoprazole produced by Takeda GmbH Sodium enteric-coated tablet (Pantoloc®, 40 mg) was used as the reference preparation. The pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ of the two preparations were compared, and the human bioequivalence of the two preparations was evaluated.
[Translation] Bioequivalence study of pantoprazole sodium enteric-coated tablets in humans
本试验旨在研究单次餐后口服湖北济安堂药业股份有限公司研制、生产的泮托拉唑钠肠溶片(40 mg)的药代动力学特征;以Takeda GmbH生产的泮托拉唑钠肠溶片(潘妥洛克®,40 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] The purpose of this experiment is to study the pharmacokinetic characteristics of pantoprazole sodium enteric-coated tablets (40 mg) developed and produced by Hubei Jiantang Pharmaceutical Co., Ltd. after a single meal; pantoprazole produced by Takeda GmbH Sodium enteric-coated tablet (Pantoloc®, 40 mg) was used as the reference preparation. The pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ of the two preparations were compared, and the human bioequivalence of the two preparations was evaluated.
[Translation] Bioequivalence study of pantoprazole sodium enteric-coated tablets in humans
本试验旨在研究单次空腹和餐后口服湖北济安堂药业股份有限公司研制、生产的泮托拉唑钠肠溶片(40 mg)的药代动力学特征;以Takeda GmbH生产的泮托拉唑钠肠溶片(潘妥洛克®,40 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] The purpose of this test is to study the pharmacokinetic characteristics of pantoprazole sodium enteric-coated tablets (40 mg) developed and produced by Hubei Jiantang Pharmaceutical Co., Ltd. after a single fasting and after meal; Pantoprazole produced by Takeda GmbH Prazol sodium enteric-coated tablet (Pantoloc®, 40 mg) was used as the reference preparation. The pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ of the two preparations were compared, and the human bioequivalence of the two preparations was evaluated.
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