/ CompletedNot Applicable 布洛芬混悬液在健康受试者中空腹与餐后条件下开放、随机、单次给药、两制剂、两序列、两周期交叉设计生物等效性试验
[Translation] An open, randomized, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of ibuprofen suspension in healthy subjects under fasting and fed conditions
研究空腹与餐后状态下单次口服受试制剂(布洛芬混悬液,规格100mL:2g,大玮(安徽)药业有限公司持证)参比制剂(布洛芬混悬液,规格100mL:2g,商品名:美林,上海强生制药有限公司持证)在健康受试者体内的药代动力学特征,比较受试制剂与参比制剂的生物等效性,并研究药物在健康受试者体内的安全性
[Translation] To study the pharmacokinetic characteristics of a single oral dose of the test preparation (ibuprofen suspension, specification 100mL:2g, licensed by Dawei (Anhui) Pharmaceutical Co., Ltd.) and the reference preparation (ibuprofen suspension, specification 100mL:2g, trade name: Meilin, licensed by Shanghai Johnson Pharmaceutical Co., Ltd.) in healthy subjects under fasting and postprandial conditions, to compare the bioequivalence of the test preparation and the reference preparation, and to study the safety of the drug in healthy subjects
/ Not yet recruitingNot Applicable 聚普瑞锌颗粒在健康受试者中空腹单次口服给药、随机、开放、两序列、两周期、交叉生物等效性预试验
[Translation] A single oral fasting, randomized, open-label, two-sequence, two-period, crossover bioequivalence pilot study of polyprezinc granules in healthy subjects
主要目的:研究空腹/餐后状态下单次口服受试制剂聚普瑞锌颗粒(规格:75mg,华益药业科技(安徽)有限公司生产(大玮(安徽)药业有限公司持证))与参比制剂聚普瑞锌颗粒(商品名:Promac®,规格:75mg;ゼリア新薬工業株式会社生产)后聚普瑞锌的体内经时过程,验证血中药物浓度分析方法以及采血时间、采样量、时间间隔等设计的合理性,初步评价两种制剂的生物等效性和计算个体内变异系数,为受试制剂的安全、合理使用提供依据。。
次要目的:评价聚普瑞锌颗粒受试制剂和参比制剂(商品名:Promac®)在健康受试者中的安全性。
[Translation] Main purpose: To study the single oral administration of the test preparation Juprezinc Granules (specification: 75mg, produced by Huayi Pharmaceutical Technology (Anhui) Co., Ltd. (certified by Dawei (Anhui) Pharmaceutical Co., Ltd.) in the fasting/postprandial state) ) and the reference preparation Polyprezinc granules (trade name: Promac®, specification: 75 mg; produced by ゼリア Shinshu Industry Co., Ltd.), the in vivo time course of Polyprezinc, verify the blood drug concentration analysis method and blood collection time, The rationality of the design of sampling volume, time interval, etc., preliminary evaluation of the bioequivalence of the two preparations and calculation of the intra-individual coefficient of variation provide a basis for the safe and reasonable use of the tested preparations. .
Secondary purpose: To evaluate the safety of the test preparation and reference preparation (trade name: Promac®) of Polyprezinc Granules in healthy subjects.
100 Clinical Results associated with Dawei (Anhui) Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Dawei (Anhui) Pharmaceutical Co., Ltd.
100 Deals associated with Dawei (Anhui) Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Dawei (Anhui) Pharmaceutical Co., Ltd.