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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date25 Jun 1965 |
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Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ 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.
注射用盐酸椒苯酮胺对心脏术后心力衰竭患者血流动力学影响的随机、单盲、安慰剂平行对照探索性临床试验
[Translation] A randomized, single-blind, placebo-controlled exploratory clinical trial on the effects of piperphentonamine hydrochloride injection on hemodynamics in patients with heart failure after cardiac surgery
(1)以安慰剂为对照,探索注射用盐酸椒苯酮胺对心脏外科手术后心力衰竭患者血流动力学影响。
(2)了解注射用盐酸椒苯酮胺用于心脏外科手术后心力衰竭患者的药代动力学(PK)/药效动力学(PD)特点,进一步评价给药方案。
[Translation] (1) Using placebo as control, explore the hemodynamic effects of piperphentonamine hydrochloride injection on patients with heart failure after cardiac surgery.
(2) Understand the pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of piperphentonamine hydrochloride injection in patients with heart failure after cardiac surgery, and further evaluate the dosing regimen.
注射用盐酸椒苯酮胺对心脏术后心力衰竭患者血流动力学影响的随机、单盲、安慰剂平行对照探索性临床试验
[Translation] A randomized, single-blind, placebo-controlled exploratory clinical trial on the effects of piperphentonamine hydrochloride injection on hemodynamics in patients with heart failure after cardiac surgery
(1)以安慰剂为对照,探索注射用盐酸椒苯酮胺对心脏外科手术后心力衰竭患者血流动力学影响。 (2)了解注射用盐酸椒苯酮胺用于心脏外科手术后心力衰竭患者的药代动力学(PK)/药效动力学(PD)特点,进一步评价给药方案。
[Translation] (1) To explore the hemodynamic effects of piperphentonamine hydrochloride injection on patients with heart failure after cardiac surgery using placebo as control. (2) To understand the pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of piperphentonamine hydrochloride injection in patients with heart failure after cardiac surgery and further evaluate the dosing regimen.
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.