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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date25 Jun 1965 |
/ CompletedNot Applicable [Translation] Study on the bioequivalence of enteric-coated aspirin tablets in healthy volunteers
本试验旨在研究单次空腹和餐后口服山东诺明康药物研究院有限公司研制、山西复盛公大药厂有限公司生产的阿司匹林肠溶片(100 mg)的药代动力学特征;以Bayer S.p.A持证、Bayer HealthCare Manufacturing S.r.l.生产的阿司匹林肠溶片(Bayaspirin®,100 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] The purpose of this study was to study the pharmacokinetic characteristics of aspirin enteric-coated tablets (100 mg) developed by Shandong Nuomingkang Pharmaceutical Research Institute Co., Ltd. and produced by Shanxi Fusheng Gongda Pharmaceutical Factory Co., Ltd. after single fasting and postprandial oral administration; enteric-coated aspirin tablets (Bayaspirin®, 100 mg) certified by Bayer S.p.A. and produced by Bayer HealthCare Manufacturing S.r.l. were used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.
100 Clinical Results associated with Shanxi Fushenggong Pharmaceutical Group Co., Ltd.
0 Patents (Medical) associated with Shanxi Fushenggong Pharmaceutical Group Co., Ltd.
100 Deals associated with Shanxi Fushenggong Pharmaceutical Group Co., Ltd.
100 Translational Medicine associated with Shanxi Fushenggong Pharmaceutical Group Co., Ltd.