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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date26 Oct 2023 |
一项随机、交叉、开放标签,评价Vamorolone口服混悬液在中国健康成年男性受试者中单次给药后的药代动力学和安全性耐受性的研究
[Translation] A randomized, crossover, open-label study to evaluate the pharmacokinetics and safety and tolerability of vamorolone oral suspension after a single dose in healthy Chinese adult male subjects
评价中国健康成年男性受试者在空腹/餐后状态下单次口服VBP15口服混悬液的安全性、耐受性和药代动力学特征。
[Translation] To evaluate the safety, tolerability, and pharmacokinetic characteristics of a single oral dose of VBP15 oral suspension in healthy Chinese adult male subjects in the fasting/fed state.
/ CompletedNot Applicable 溴吡斯的明片与溴吡斯的明缓释片人体药代动力学对比研究
[Translation] Comparative study on the pharmacokinetics of pyridostigmine bromide tablets and pyridostigmine bromide sustained-release tablets in healthy volunteers
试验的主要目的:获得空腹口服溴吡斯的明片和溴吡斯的明缓释片后中国健康成年人中药代动力学数据,并对比溴吡斯的明片和溴吡斯的明缓释片的药代动力学特征。
试验的次要目的:评价中国健康成年人空腹口服溴吡斯的明缓释片后的安全性。
[Translation] The primary purpose of the trial is to obtain the pharmacokinetic data of pyridostigmine bromide tablets and pyridostigmine bromide sustained-release tablets in healthy Chinese adults after oral administration on an empty stomach, and to compare the pharmacokinetic characteristics of pyridostigmine bromide tablets and pyridostigmine bromide sustained-release tablets.
The secondary purpose of the trial is to evaluate the safety of pyridostigmine bromide sustained-release tablets in healthy Chinese adults after oral administration on an empty stomach.
100 Clinical Results associated with Beijing Hanyou Pharmaceutical Technology Co., Ltd
0 Patents (Medical) associated with Beijing Hanyou Pharmaceutical Technology Co., Ltd
100 Deals associated with Beijing Hanyou Pharmaceutical Technology Co., Ltd
100 Translational Medicine associated with Beijing Hanyou Pharmaceutical Technology Co., Ltd