[Translation] Bioequivalence trial of iguratimod tablets
主要研究目的
评价中国健康成年受试者空腹及餐后条件下单次单剂量口服艾拉莫德片受试制剂(规格:25mg,申办者:安徽正善生物药业有限公司)和参比制剂(商品名:艾得辛®,规格:25mg,持证商:海南先声药业有限公司)后的药代动力学特点和生物等效性。
次要研究目的
研究艾拉莫德片受试制剂(规格:25mg)和参比制剂(商品名:艾得辛®,规格:25mg)在中国健康成年受试者中的安全性。
[Translation] Main research purpose
Evaluation of the test preparation (specification: 25 mg, sponsor: Anhui Zhengshan Biopharmaceutical Co., Ltd.) and the reference preparation (trade name: Pharmacokinetic characteristics and bioequivalence of Edesin®, specification: 25mg, license holder: Hainan Simcere Pharmaceutical Co., Ltd.).
Secondary research purpose
To study the safety of the test preparation (specification: 25mg) and reference preparation (trade name: Aidexin®, specification: 25mg) of iguratimod tablets in healthy Chinese adult subjects.
[Translation] Bioequivalence trial of iguratimod tablets
主要研究目的
评价中国健康成年受试者空腹及餐后条件下单次单剂量口服艾拉莫德片受试制剂(规格:25mg,申办者:安徽正善生物药业有限公司)和参比制剂(商品名:艾得辛®,规格:25mg,持证商:海南先声药业有限公司)后的药代动力学特点和生物等效性。
次要研究目的
研究艾拉莫德片受试制剂(规格:25mg)和参比制剂(商品名:艾得辛®,规格:25mg)在中国健康成年受试者中的安全性。
[Translation] Main research purpose
Evaluation of the test preparation (specification: 25 mg, sponsor: Anhui Zhengshan Biopharmaceutical Co., Ltd.) and the reference preparation (trade name: Pharmacokinetic characteristics and bioequivalence of Adexin®, specification: 25mg, license holder: Hainan Simcere Pharmaceutical Co., Ltd.).
Secondary research purpose
To study the safety of the test preparation (specification: 25mg) and reference preparation (trade name: Aidexin®, specification: 25mg) of iguratimod tablets in healthy Chinese adult subjects.
[Translation] Bioequivalence test of fluvoxamine maleate tablets
主要研究目的
评价中国健康成年受试者空腹及餐后条件下单次单剂量口服马来酸氟伏沙明片受试制剂(规格:100mg,申办者:安徽正善生物药业有限公司)和参比制剂(商品名:Luvox®(兰释®),规格:100mg,持证商:Abbott Laboratories (Singapore) Private Limited)后的药代动力学特点和生物等效性。
次要研究目的
研究马来酸氟伏沙明片受试制剂(规格:100mg)和参比制剂(商品名:Luvox®(兰释®),规格:100mg)在中国健康成年受试者中的安全性。
[Translation] Main research purpose
Evaluation of the test preparation (specification: 100 mg, sponsor: Anhui Zhengshan Biopharmaceutical Co., Ltd.) and the reference preparation (Single-dose oral administration of fluvoxamine maleate tablets) in Chinese healthy adult subjects under fasting and postprandial conditions Trade name: Luvox® (Lanshi®), specification: 100mg, licensee: Abbott Laboratories (Singapore) Private Limited), pharmacokinetic characteristics and bioequivalence.
Secondary research purpose
To study the safety of the test preparation (specification: 100mg) of fluvoxamine maleate tablets and the reference preparation (trade name: Luvox®, specification: 100mg) in healthy adult subjects in China.
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