瑞巴派特片(100mg)在中国健康受试者中空腹及餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验
[Translation] Randomized, open-label, single-dose, two-sequence, two-cycle, double-crossover bioequivalence trial of rebamipide tablets (100mg) under fasting and postprandial dosing conditions in healthy Chinese subjects
主要研究目的:
按有关生物等效性试验的规定,选择大塚制薬株式会社 (OTSUKA PHARMACEUTICAL Co.,Ltd.)生产的瑞巴派特片(商品名: Mucosta®,规格:100mg/片)为参比制剂,对浙江金华康恩贝生物制药有限公司生产、杭州默银医药技术有限公司提供的受试制剂瑞巴派特片(规格:100mg/片)进行空腹及餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,比较两种制剂在空腹及餐后给药条件下的生物等效性。
次要研究目的:
观察健康志愿受试者口服受试制剂瑞巴派特片(规格: 100mg/片)和参比制剂瑞巴派特片(商品名:Mucosta®,规格:100mg/片)的安全性。
[Translation] Main research purposes:
According to the relevant bioequivalence test regulations, rebamipide tablets (trade name: Mucosta®, specification: 100mg/tablet) produced by OTSUKA PHARMACEUTICAL Co., Ltd. were selected as the reference preparation. The human bioequivalence test of rebamipide tablets (specification: 100mg/tablet) produced by Zhejiang Jinhua Kangenbei Biopharmaceutical Co., Ltd. and provided by Hangzhou Moyin Pharmaceutical Technology Co., Ltd. was conducted on an empty stomach and after meals. Compare whether the difference between the absorption rate and degree of absorption of the drug in the test preparation and the reference preparation is within an acceptable range, and compare the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary research purposes:
To observe the safety of healthy volunteers taking the test preparation rebamipide tablets (specification: 100mg/tablet) and the reference formulation rebamipide tablets (trade name: Mucosta®, specification: 100mg/tablet).
瑞巴派特片(100mg)在中国健康受试者中空腹及餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验
[Translation] Randomized, open-label, single-dose, two-sequence, two-cycle, double-crossover bioequivalence trial of rebamipide tablets (100mg) under fasting and postprandial dosing conditions in healthy Chinese subjects
主要研究目的:按有关生物等效性试验的规定,选择大塚制薬株式会社(OTSUKA PHARMACEUTICAL Co.,Ltd.)生产的瑞巴派特片(商品名:Mucosta,规格:100mg/片)为参比制剂,对浙江金华康恩贝生物制药有限公司生产、杭州默银医药技术有限公司提供的受试制剂瑞巴派特片(规格:100mg/片)进行空腹及餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,比较两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的:观察健康志愿受试者口服受试制剂瑞巴派特片(规格:100mg/片)和参比制剂瑞巴派特片(商品名:Mucosta,规格:100mg/片)的安全性
[Translation] Main research purpose: According to the relevant provisions of the bioequivalence test, rebamipide tablets (trade name: Mucosta, specification: 100mg/tablet) produced by OTSUKA PHARMACEUTICAL Co., Ltd. were selected as reference materials. Compared with the preparation, the test preparation Rebamipide tablets (specification: 100mg/tablet) produced by Zhejiang Jinhua Kangenbei Bio-Pharmaceutical Co., Ltd. and provided by Hangzhou Moyin Pharmaceutical Technology Co., Ltd. were bioequivalent to human beings administered on an empty stomach and after meals. To compare whether the difference between the absorption rate and degree of absorption of the drug in the test preparation and the reference preparation is within an acceptable range, and compare the bioequivalence of the two preparations under the conditions of fasting and postprandial administration.
Secondary research purpose: To observe the safety of oral test preparation rebamipide tablets (specification: 100mg/tablet) and reference preparation rebamipide tablets (trade name: Mucosta, specification: 100mg/tablet) in healthy volunteers sex
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