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Inactive Indication- |
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 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.
/ CompletedNot Applicable 托伐普坦口崩片在中国健康成年参与者中的生物等效性研究
[Translation] Bioequivalence study of tolvaptan orally disintegrating tablets in healthy Chinese adult 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] Primary study objectives: 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.
Secondary study objectives: To evaluate the safety of the test and reference formulations in healthy Chinese adults.
/ CompletedNot Applicable [Translation] Bioequivalence study of Pemabet tablets in healthy Chinese adult 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] Primary study objectives: 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.
Secondary study objectives: 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.