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MechanismA2aR antagonists |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.JP |
First Approval Date25 Mar 2013 |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CO |
First Approval Date29 Jun 2012 |
Target- |
Mechanism- |
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Inactive Indication- |
Drug Highest PhaseIND Approval |
First Approval Ctry. / Loc.- |
First Approval Date- |
苯磺酸左氨氯地平片在中国成年健康受试者中的生物等效性研究
[Translation] Bioequivalence Study of Levamlodipine Besylate Tablets in Chinese Adult Healthy Subjects
主要研究目的:研究空腹/餐后状态下口服受试制剂苯磺酸左氨氯地平片(江西施美药业股份有限公司生产)与参比制剂苯磺酸氨氯地平片(络活喜®,辉瑞制药有限公司生产)在中国健康成年受试者体内的药代动力学特征,评价空腹/餐后状态口服两种制剂的生物等效性。
次要研究目的:评估受试制剂苯磺酸左氨氯地平片和参比制剂苯磺酸氨氯地平片(络活喜®)在中国健康成年受试者中的安全性。
[Translation] Main research purpose: To study the oral administration of the test preparation Levamlodipine Besylate Tablets (produced by Jiangxi Shimei Pharmaceutical Co., Ltd.) and the reference preparation Amlodipine Besylate Tablets (Norflox®) in the fasting/postprandial state. , produced by Pfizer Pharmaceuticals Co., Ltd.) in healthy Chinese adult subjects to evaluate the bioequivalence of the two oral formulations in the fasting/postprandial state.
Secondary study purpose: To evaluate the safety of the test formulation Levamlodipine Besylate Tablets and the reference formulation Amlodipine Besylate Tablets (Norvasc®) in healthy adult subjects in China.
精氨酸培哚普利片在中国成年健康受试者中的生物等效性研究
[Translation] Bioequivalence study of Arginine Perindopril Tablets in Chinese adult healthy subjects
主要研究目的:研究空腹/餐后状态下口服受试制剂精氨酸培哚普利片(江西施美药业股份有限公司生产)与参比制剂精氨酸培哚普利片(COVERSYL®,Les Laboratoires Servier生产)在中国健康成年受试者体内的药代动力学特征,评价空腹/餐后状态口服两种制剂的生物等效性。
次要研究目的:评估受试制剂精氨酸培哚普利片和参比制剂精氨酸培哚普利片(COVERSYL®)在中国健康成年受试者中的安全性。
[Translation] Main research purpose: To study the oral administration of the test preparation Arginine Perindopril Tablets (produced by Jiangxi Shimei Pharmaceutical Co., Ltd.) and the reference preparation Arginine Perindopril Tablets (COVERSYL®, Pharmacokinetic characteristics of Les Laboratoires Servier) in healthy Chinese adult subjects to evaluate the bioequivalence of two oral preparations in the fasting/postprandial state.
Secondary study purpose: To evaluate the safety of the test formulation Arginine Perindopril Tablets and the reference formulation Arginine Perindopril Tablets (COVERSYL®) in healthy adult subjects in China.
美阿沙坦钾片在中国成年健康受试者中的生物等效性研究
[Translation] Bioequivalence Study of Measartan Potassium Tablets in Chinese Adult Healthy Subjects
主要研究目的
研究空腹/餐后状态下口服受试制剂美阿沙坦钾片(江西施美药业股份有限公司生产)与参比制剂美阿沙坦钾片(易达比®,Takeda Ireland Ltd.生产)在中国健康成年受试者体内的药代动力学特征,评价空腹/餐后状态口服两种制剂的生物等效性。
次要研究目的
评估受试制剂美阿沙坦钾片和参比制剂美阿沙坦钾片(易达比®)在中国健康成年受试者中的安全性。
[Translation] Main research purpose
Study the oral administration of the test preparation Measartan Potassium Tablets (produced by Jiangxi Shimei Pharmaceutical Co., Ltd.) and the reference preparation Measartan Potassium Tablets (produced by Takeda Ireland Ltd.) in the fasting/postprandial state in China Pharmacokinetic characteristics in healthy adult subjects to evaluate the bioequivalence of the two oral formulations in the fasting/postprandial state.
Secondary research purpose
To evaluate the safety of the test preparation Measartan Potassium Tablets and the reference preparation Measartan Potassium Tablets (Edabi®) in healthy adult subjects in China.
100 Clinical Results associated with Jiangxi Shimei Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Jiangxi Shimei Pharmaceutical Co., Ltd.
100 Deals associated with Jiangxi Shimei Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Jiangxi Shimei Pharmaceutical Co., Ltd.