[Translation] Bioequivalence study of arginine ibuprofen granules in healthy volunteers
主要目的:在健康受试者体内,分别在空腹和餐后条件下,以海南赞邦制药有限公司持有的精氨酸布洛芬颗粒(商品名:司百得®;规格:0.4g(以布洛芬计))为参比制剂,研究仁合益康汇泽药业河北有限公司持有的精氨酸布洛芬颗粒(规格:0.4g(以布洛芬计),受试制剂)的人体药代动力学,评价受试制剂与参比制剂是否具有生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: To study the pharmacokinetics of arginine ibuprofen granules (specification: 0.4g (in terms of ibuprofen), test preparation) held by Renhe Yikang Huize Pharmaceutical Hebei Co., Ltd. in healthy subjects under fasting and postprandial conditions, using arginine ibuprofen granules (trade name: Spodek®; specification: 0.4g (in terms of ibuprofen)) held by Hainan Zanbang Pharmaceutical Co., Ltd. as the reference preparation, and evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.
[Translation] Bioequivalence study of ivocate tablets
主要试验目的:在健康受试者体内,分别在空腹和餐后状态下,以協和キリン株式会社持有的依伏卡塞片(规格:2 mg;商品名:Orkedia®)为参比制剂,研究仁合益康汇泽药业河北有限公司研制的依伏卡塞片(规格:2 mg;受试制剂)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。
次要试验目的: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 of the test: In healthy subjects, under fasting and postprandial conditions, evocarnet tablets (specification: 2 mg; trade name: Orkedia®) held by Kyowa Coron Co., Ltd. were used as the reference preparation. Study the pharmacokinetics of evocarnet tablets (specification: 2 mg; test preparation) developed by Renhe Yikang Huize Pharmaceutical Hebei Co., Ltd., and evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary test purpose: to observe the safety of the test preparation and reference preparation in healthy subjects.
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