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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.JP |
First Approval Date22 Apr 2009 |
一项评价替比培南匹酯细粒剂在中国健康成年男性受试者中单次口服给药的药代动力学及食物影响的临床研究
[Translation] A clinical study to evaluate the pharmacokinetics and food effects of a single oral dose of tebipenem pivoxil fine granules in healthy Chinese adult male subjects
主要目的:考察中国健康成年男性单次口服替比培南匹酯细粒剂后的药代动力学特征;
次要目的:考察食物对替比培南细粒剂的药代动力学特征的影响;考察中国健康成年男性单次口服替比培南匹酯细粒剂后的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic characteristics of tebipenem pivoxil fine granules in healthy Chinese adult males after a single oral administration;
Secondary objective: To investigate the effect of food on the pharmacokinetic characteristics of tebipenem pivoxil fine granules; To investigate the safety of tebipenem pivoxil fine granules in healthy Chinese adult males after a single oral administration.
100 Clinical Results associated with Hangzhou Beijia Pharmaceutical Technology Co., Ltd.
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100 Translational Medicine associated with Hangzhou Beijia Pharmaceutical Technology Co., Ltd.