/ CompletedNot Applicable 布洛芬混悬液(100 mL:2 g)健康人体生物等效性研究
[Translation] Bioequivalence study of ibuprofen suspension (100 mL: 2 g) in healthy volunteers
主要目的:本研究以福建太平洋制药有限公司研制的布洛芬混悬液(规格:100 mL:2g)为受试制剂,按生物等效性研究的有关规定,以原研地产化生产企业上海强生制药有限公司生产的布洛芬混悬液(商品名称:美林®,规格:100 毫升:2克)为参比制剂,评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。
次要目的:观察受试制剂布洛芬混悬液和参比制剂布洛芬混悬液(商品名称:美林®)在健康受试者中的安全性。
[Translation] Primary purpose: This study uses ibuprofen suspension (specification: 100 mL: 2g) developed by Fujian Pacific Pharmaceutical Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, ibuprofen suspension (trade name: Meilin®, specification: 100 mL: 2g) produced by the original research and development localization manufacturer Shanghai Johnson Pharmaceutical Co., Ltd. is used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions.
Secondary purpose: To observe the safety of the test preparation ibuprofen suspension and the reference preparation ibuprofen suspension (trade name: Meilin®) in healthy subjects.
/ CompletedNot Applicable 布洛芬缓释胶囊随机、开放、两周期、交叉健康人体空腹/餐后状态下生物等效性试验
[Translation] A randomized, open, two-period, crossover bioequivalence study of ibuprofen sustained-release capsules in healthy volunteers under fasting and fed conditions
主要目的:本研究以福建太平洋制药有限公司研发的布洛芬缓释胶囊(规格:0.3 g)为受试制剂,按生物等效性研究的有关规定,以原研厂家中美天津史克制药有限公司生产的布洛芬缓释胶囊(规格:0.3 g,商品名:芬必得)为参比制剂,评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。
[Translation] Main objective: This study used ibuprofen sustained-release capsules (specification: 0.3 g) developed by Fujian Pacific Pharmaceutical Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, ibuprofen sustained-release capsules (specification: 0.3 g, trade name: Fenbid) produced by the original manufacturer Sino-US Tianjin SmithKline Pharmaceutical Co., Ltd. were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions.
100 Clinical Results associated with Fujian Taipingyang Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Fujian Taipingyang Pharmaceutical Co. Ltd.
100 Deals associated with Fujian Taipingyang Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Fujian Taipingyang Pharmaceutical Co. Ltd.