[Translation] Human bioequivalence trial of clopidogrel bisulfate tablets
主要研究目的
本研究考察空腹及餐后条件下单次口服受试制剂硫酸氢氯吡格雷片(规格:75 mg/片,生产单位:杭州民生药业股份有限公司)与参比制剂硫酸氢氯吡格雷片(商品名:波立维®,规格:75 mg/片,生产单位:Sanofi Wint hrop Industrie)在健康成年受试者体内的药代动力学,评价空腹和餐后口服两种制剂的生物等效性。
次要研究目的
观察单次口服 75 mg 的受试制剂硫酸氢氯吡格雷片或参比制剂硫酸氢氯吡格雷片(商品名:波立维®,75 mg)在健康受试者中的安全性。
[Translation] Main research purpose
This study examines the single oral administration of the test preparation Clopidogrel Hydrogen Sulfate Tablets (specification: 75 mg/tablet, production unit: Hangzhou Minsheng Pharmaceutical Co., Ltd.) and the reference preparation Clopidogrel Hydrogen Sulfate Tablets under fasting and postprandial conditions. (Trade name: Plavix®, strength: 75 mg/tablet, production unit: Sanofi Winthrop Industrie) Pharmacokinetics in healthy adult subjects, to evaluate the bioequivalence of two formulations taken orally on an empty stomach and after a meal .
Secondary research purpose
Observe the safety of a single oral administration of 75 mg of the test preparation Clopidogrel Hydrogen Sulfate Tablets or the reference preparation Clopidogrel Hydrogen Sulfate Tablets (trade name: Plavix®, 75 mg) in healthy subjects.
[Translation] Human bioequivalence trial of finasteride tablets
主要目的:
比较空腹和餐后给药条件下单次口服海南药谷云生物科技有限公司委托南京海鲸药业股份有限公司生产的非那雄胺片(规格:5 mg)与Merck Sharp & Dohme Limited持证的非那雄胺片(商品名:保列治®;规格:5 mg)在健康人群中吸收程度和速度的差异,评价空腹和餐后状态下口服两种制剂的生物等效性。
次要目的:
评价空腹和餐后给药条件下,单次口服海南药谷云生物科技有限公司委托南京海鲸药业股份有限公司生产的非那雄胺片(规格:5 mg)与Merck Sharp & Dohme Limited持证的非那雄胺片(商品名:保列治®;规格:5 mg)的安全性和耐受性。
[Translation] main purpose:
Compare the single oral administration of finasteride tablets (specification: 5 mg) produced by Hainan Yaoguyun Biotechnology Co., Ltd. and Nanjing Haijing Pharmaceutical Co., Ltd. under fasting and postprandial administration conditions with those licensed by Merck Sharp & Dohme Limited To evaluate the differences in the degree and speed of absorption of Finasteride tablets (trade name: Proscar®; strength: 5 mg) in healthy people, and to evaluate the bioequivalence of the two oral preparations in the fasting and postprandial states.
Secondary purpose:
Evaluation of a single oral dose of finasteride tablets (specification: 5 mg) produced by Hainan Yaoguyun Biotechnology Co., Ltd. and commissioned by Nanjing Haijing Pharmaceutical Co., Ltd. in partnership with Merck Sharp & Dohme Limited under fasting and postprandial administration conditions. The safety and tolerability of proven finasteride tablets (trade name: Proscar®; strength: 5 mg).
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