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Mechanismfactor Xa inhibitors |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc. |
First Approval Date18 May 2011 |
[Translation] Bioequivalence trial of pitavastatin calcium orally disintegrating tablets
主要研究目的
研究空腹和餐后状态下单次口服受试制剂匹伐他汀钙口崩片(规格:4mg,广东万泰科创药业有限公司提供)与参比制剂匹伐他汀钙口崩片(Livalo OD,规格:4mg,持证商:興和株式会社),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
评价中国健康受试者空腹和餐后状态下,单次口服受试制剂匹伐他汀钙口崩片和参比制剂匹伐他汀钙口崩片(Livalo OD)后的安全性。
[Translation] Main research purpose
Study the single oral administration of the test preparation pitavastatin calcium orally disintegrating tablets (specification: 4 mg, provided by Guangdong Wantai Kechuang Pharmaceutical Co., Ltd.) and the reference preparation pitavastatin calcium orally disintegrating tablets (Livalo OD) in the fasting and postprandial states. , Specification: 4mg, Licensee: Kowa Co., Ltd.), pharmacokinetics in healthy adult subjects, and evaluate the bioequivalence of the two preparations taken orally on an empty stomach and after a meal.
Secondary research purpose
To evaluate the safety of Chinese healthy subjects after a single oral administration of the test preparation pitavastatin calcium orally disintegrating tablets and the reference preparation pitavastatin calcium orally disintegrating tablets (Livalo OD) in fasting and postprandial states.
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