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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.South Korea |
First Approval Date31 Jan 2013 |
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MechanismL-type calcium channel blockers [+1] |
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Inactive Indication- |
Drug Highest PhaseNDA/BLA |
First Approval Ctry. / Loc.- |
First Approval Date- |
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Inactive Indication- |
Drug Highest PhaseNDA/BLA |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ CompletedNot Applicable [Translation] Bioequivalence study of fenelazol tablets in healthy adult participants in China
主要研究目的:研究空腹状态下口服受试制剂与参比制剂在中国健康成年参与者体内的药代动力学特征,评价空腹状态口服两种制剂的生物等效性。 次要研究目的:评估受试制剂和参比制剂在中国健康成年参与者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic characteristics of the test formulation and the reference formulation in healthy adult participants in China under fasting conditions, and to evaluate their bioequivalence under fasting conditions. Secondary objective: To assess the safety of the test formulation and the reference formulation in healthy adult participants in China.
/ CompletedNot Applicable 乌帕替尼缓释片在中国健康成年参与者中的生物等效性研究
[Translation] Bioequivalence study of utpatinib extended-release tablets in healthy adult participants in China
主要研究目的:研究空腹/餐后状态下口服受试制剂与参比制剂在中国健康成年参与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:评估受试制剂和参比制剂在中国健康成年参与者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic characteristics of the test formulation and the reference formulation in healthy adult participants in China under fasting and postprandial conditions, and to evaluate the bioequivalence of the two formulations under fasting and postprandial conditions. Secondary objective: To assess the safety of the test formulation and the reference formulation in healthy adult participants in China.
/ CompletedNot Applicable 苯磺酸美洛加巴林片在中国健康参与者中的生物等效性研究
[Translation] Bioequivalence study of melogabalin besylate tablets in Chinese healthy participants
主要研究目的:研究空腹/餐后状态下口服受试制剂与参比制剂在中国健康成年参与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:评估受试制剂和参比制剂在中国健康成年参与者中的安全性。
[Translation] The primary study objective was to investigate the pharmacokinetic characteristics of the test and reference formulations in healthy Chinese adults after oral administration in the fasting and fed states, and to evaluate the bioequivalence of the two formulations after oral administration in the fasting and fed states. The secondary study objective was to evaluate the safety of the test and reference formulations in healthy Chinese adults.
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.