[Translation] Study on the bioequivalence of loxoprofen sodium patch in healthy volunteers
主要目的:采用单中心、随机、开放、两制剂、双周期交叉、空腹试验设计,比较空腹给药条件下,金鸿药业股份有限公司提供的洛索洛芬钠贴剂(100 mg/贴(10 cm×14 cm))与Lead Chemical Co., Ltd持证的洛索洛芬钠贴剂(规格:100 mg/贴(10 cm×14 cm))在中国健康人群中吸收程度和吸收速度的差异,评价生物等效性。
次要目的:1)评价受试制剂与参比制剂在中国健康受试者中的安全性;2)评价受试制剂与参比制剂在中国健康受试者用药过程中的黏附性;3)评价受试制剂与参比制剂对中国健康受试者的皮肤反应性。
[Translation] Primary objective: To compare the differences in the absorption extent and absorption rate of loxoprofen sodium patch (100 mg/patch (10 cm×14 cm)) provided by Jinhong Pharmaceutical Co., Ltd. and loxoprofen sodium patch (specification: 100 mg/patch (10 cm×14 cm)) certified by Lead Chemical Co., Ltd. in Chinese healthy population under fasting administration conditions using a single-center, randomized, open, two-drug, two-period crossover, fasting trial design, and evaluate bioequivalence.
Secondary objectives: 1) To evaluate the safety of the test preparation and the reference preparation in Chinese healthy subjects; 2) To evaluate the adhesion of the test preparation and the reference preparation during medication in Chinese healthy subjects; 3) To evaluate the skin reactivity of the test preparation and the reference preparation in Chinese healthy subjects.
[Translation] Bioequivalence study of Ibrutinib capsules
主要研究目的:
评价中国健康成年受试者空腹条件下单次单剂量口服伊布替尼胶囊受试制剂(规格:0.14g,申办者:金鸿药业股份有限公司)和参比制剂(商品名:亿珂®,规格:140mg,持证商:Janssen-Cilag International NV)后的药代动力学特点和生物等效性。
次要研究目的:
研究伊布替尼胶囊受试制剂(规格:0.14g)和参比制剂(商品名:亿珂®,规格:140mg)在中国健康成年受试者中的安全性。
[Translation] Main study objectives:
To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of ibrutinib capsules (specification: 0.14g, applicant: Jinhong Pharmaceutical Co., Ltd.) and the reference formulation (trade name: Yike®, specification: 140mg, licensee: Janssen-Cilag International NV) after a single oral dose under fasting conditions in healthy Chinese adult subjects.
Secondary study objectives:
To study the safety of the test formulation of ibrutinib capsules (specification: 0.14g) and the reference formulation (trade name: Yike®, specification: 140mg) in healthy Chinese adult subjects.
[Translation] Bioequivalence study of Ibrutinib capsules
主要研究目的:
评价中国健康成年受试者餐后条件下单次单剂量口服伊布替尼胶囊受试制剂(规格:0.14g,申办者:金鸿药业股份有限公司)和参比制剂(商品名:亿珂®,规格:140mg,持证商:Janssen-Cilag International NV)后的药代动力学特点和生物等效性。
次要研究目的:
研究伊布替尼胶囊受试制剂(规格:0.14g)和参比制剂(商品名:亿珂®,规格:140mg)在中国健康成年受试者中的安全性。
[Translation] Main study objectives:
To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of ibrutinib capsules (specification: 0.14g, applicant: Jinhong Pharmaceutical Co., Ltd.) and the reference formulation (trade name: Yike®, specification: 140mg, licensee: Janssen-Cilag International NV) after a single oral dose under postprandial conditions in healthy Chinese adult subjects.
Secondary study objectives:
To study the safety of the test formulation of ibrutinib capsules (specification: 0.14g) and the reference formulation (trade name: Yike®, specification: 140mg) in healthy Chinese adult subjects.
100 Clinical Results associated with Zhuhai Kinhoo Pharmaceutical Co. Ltd.
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