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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date14 Apr 2020 |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date01 Jan 1994 |
/ Not yet recruitingNot Applicable [Translation] Equivalence test of enteric-coated aspirin 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阿司匹林肠溶片受试制剂(规格:100mg,申办者:黑龙江省林宝药业有限责任公司)和参比制剂(商品名:拜阿司匹灵®,规格:100mg,持证商:Bayer S.p.A.)后的药代动力学特点和生物等效性。
次要研究目的
研究阿司匹林肠溶片受试制剂(规格:100mg)和参比制剂(商品名:拜阿司匹灵®,规格:100mg)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 aspirin enteric-coated tablets (specification: 100 mg, applicant: Heilongjiang Linbao Pharmaceutical Co., Ltd.) and reference preparation (trade name: Bayer Aspirin®, specification: 100 mg, licensee: Bayer S.p.A.) after a single oral dose in healthy Chinese adult subjects under fasting and postprandial conditions.
Secondary study objectives
To study the safety of aspirin enteric-coated tablets (specification: 100 mg) and reference preparation (trade name: Bayer Aspirin®, specification: 100 mg) in healthy Chinese adult subjects.
100 Clinical Results associated with Heilongjiang Linbao Pharmaceutical Co., Ltd
0 Patents (Medical) associated with Heilongjiang Linbao Pharmaceutical Co., Ltd
100 Deals associated with Heilongjiang Linbao Pharmaceutical Co., Ltd
100 Translational Medicine associated with Heilongjiang Linbao Pharmaceutical Co., Ltd