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/ CompletedNot Applicable 吡拉西坦片随机、开放、交叉设计在中国健康受试者中的生物等效性正式试验
[Translation] A formal randomized, open-label, crossover bioequivalence trial of piracetam tablets in Chinese healthy subjects
主要目的:以福建省福抗药业股份有限公司的吡拉西坦片为受试制剂;并以UCB Pharma S.A.的吡拉西坦片为参比制剂,进行人体相对生物利用度和生物等效性评价。
[Translation] Main objective: To evaluate the relative bioavailability and bioequivalence of piracetam tablets produced by Fujian Fukang Pharmaceutical Co., Ltd. as the test preparation and piracetam tablets produced by UCB Pharma S.A. as the reference preparation in humans.
/ Not yet recruitingPhase 1 注射用头孢拉宗钠在中国健康人体的单次和多次药代动力学试验
[Translation] Single and repeated pharmacokinetic studies of cefuroxime sodium for injection in healthy Chinese subjects
选择健康志愿者进行注射用头孢拉宗钠在人体的单次和多次药代动力学试验,通过进行低、中、高剂量单次和中剂量多次药代动力学试验,测定头孢拉宗的经时血药浓度,估算其主要药代动力学参数,了解注射用头孢拉宗钠在健康人体内的吸收、分布、消除规律,为制定后期试验方案提供试验依据,为临床用药的给药剂量提供依据。
[Translation] Healthy volunteers were selected to conduct single and multiple pharmacokinetic trials of cefuroxime sodium for injection in humans. By conducting low-, medium- and high-dose single and medium-dose multiple pharmacokinetic trials, the time-dependent blood concentration of cefuroxime sodium was determined, its main pharmacokinetic parameters were estimated, and the absorption, distribution and elimination patterns of cefuroxime sodium for injection in healthy humans were understood, providing an experimental basis for formulating subsequent test plans and a basis for clinical drug dosage.
100 Clinical Results associated with Fujian Fukang Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Fujian Fukang Pharmaceutical Co. Ltd.
100 Deals associated with Fujian Fukang Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Fujian Fukang Pharmaceutical Co. Ltd.