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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.KR |
First Approval Date13 Aug 2012 |
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MechanismGABAA receptor agonists |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.JP |
First Approval Date29 Mar 1988 |
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MechanismDRDs antagonists |
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Originator Org.- |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.- |
First Approval Date- |
在健康受试者中评价高脂餐和低脂餐对盐酸阿姆西汀肠溶片药代动力学影响的单剂量、随机、开放、三序列、三周期交叉的临床试验
[Translation] A single-dose, randomized, open-label, three-sequence, three-period crossover clinical trial to evaluate the effects of high-fat and low-fat meals on the pharmacokinetics of enteric-coated amoxicillin hydrochloride tablets in healthy subjects
主要目的:在健康受试者中评价高脂餐和低脂餐对单次口服盐酸阿姆西汀肠溶片药代动力学特征的影响
次要目的:在健康受试者中评价高脂餐和低脂餐对单次口服盐酸阿姆西汀肠溶片后的安全性和耐受性
[Translation] Primary objective: To evaluate the effects of high-fat and low-fat meals on the pharmacokinetic characteristics of a single oral dose of enteric-coated amuletine hydrochloride tablets in healthy subjects
Secondary objective: To evaluate the safety and tolerability of a single oral dose of enteric-coated amuletine hydrochloride tablets in healthy subjects after a high-fat and low-fat meal
评价中国健康成年受试者口服巴旋片单次和多次给药剂量递增的安全性、耐受性及药代动力学探索的 I 期临床试验
[Translation] A phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of oral Baxuan tablets in healthy Chinese adult subjects
1、评价中国健康成年受试者中口服巴旋片单次给药安全性、耐受性;
2、评价中国健康成年受试者中口服巴旋片多次给药安全性、耐受性;
3、探索中国健康成年受试者中口服巴旋片的药代动力学特征。
[Translation] 1. Evaluate the safety and tolerability of single-dose oral Baxuan tablets in healthy Chinese adult subjects;
2. Evaluate the safety and tolerability of multiple-dose oral Baxuan tablets in healthy Chinese adult subjects;
3. Explore the pharmacokinetic characteristics of oral Baxuan tablets in healthy Chinese adult subjects.
[Translation] Study on the bioequivalence of oseltamivir phosphate orally disintegrating tablets in healthy volunteers
本试验旨在研究单次空腹和餐后口服北京星昊医药股份有限公司研制、北京星昊盈盛药业有限公司生产的磷酸奥司他韦口崩片(星昊美盈®,30 mg)的药代动力学特征;以Roche Pharma AG 生产的磷酸奥司他韦干混悬剂(Tamiflu®,6 mg/mL)为参比制剂,比较两制剂的药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性,及高脂高热量餐对受试制剂生物利用度的影响。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of a single fasting and postprandial oral administration of oseltamivir phosphate orodisintegrating tablets (Xinghao Meiying®, 30 mg) developed by Beijing Xinghao Pharmaceutical Co., Ltd. and produced by Beijing Xinghao Yingsheng Pharmaceutical Co., Ltd.; using oseltamivir phosphate dry suspension (Tamiflu®, 6 mg/mL) produced by Roche Pharma AG as the reference preparation, to compare the pharmacokinetic parameters of the two preparations, including Cmax, AUC0-t, and AUC0-∞, to evaluate the bioequivalence of the two preparations in humans, and to evaluate the effect of a high-fat and high-calorie meal on the bioavailability of the test preparation.
100 Clinical Results associated with Institute of Poisons and Drugs, Academy of Military Medical Sciences, PLA
0 Patents (Medical) associated with Institute of Poisons and Drugs, Academy of Military Medical Sciences, PLA
100 Deals associated with Institute of Poisons and Drugs, Academy of Military Medical Sciences, PLA
100 Translational Medicine associated with Institute of Poisons and Drugs, Academy of Military Medical Sciences, PLA