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泊沙康唑肠溶片在健康受试者中空腹和餐后状态下的随机、开放、两周期、双交叉生物等效性临床试验
[Translation] A randomized, open-label, two-period, double-crossover bioequivalence clinical trial of posaconazole enteric-coated tablets in healthy subjects under fasting and fed conditions
研究空腹及餐后状态下,单次口服泊沙康唑肠溶片受试制剂(规格:100mg,扬子江药业集团有限公司)与参比制剂(诺科飞®,规格:100mg,持证商:Merck Sharp & Dohme Ltd;生产商:N.V.Organon)在健康受试者中的药代动力学行为,评价两种制剂的生物等效性。评价受试制剂和参比制剂(商品名:诺科飞®)在健康受试者中的安全性。
[Translation] The pharmacokinetic behavior of the test formulation of posaconazole enteric-coated tablets (specification: 100 mg, Yangtze River Pharmaceutical Group Co., Ltd.) and the reference formulation (NocoFy®, specification: 100 mg, licensee: Merck Sharp & Dohme Ltd; manufacturer: N.V.Organon) in healthy subjects after a single oral administration in the fasting and postprandial state was studied to evaluate the bioequivalence of the two formulations. The safety of the test formulation and the reference formulation (trade name: NocoFy®) in healthy subjects was evaluated.
/ CompletedNot Applicable 克立硼罗软膏在健康受试者中空腹状态下的随机、开放、双周期、双交叉生物等效性临床试验
[Translation] A randomized, open-label, two-period, double-crossover bioequivalence clinical trial of crisaborole ointment in healthy subjects under fasting condition
研究空腹状态下,单次使用克立硼罗软膏受试制剂(规格:每克本品含20mg克立硼罗(2%),江苏海岸药业有限公司提供)与参比制剂(商品名:舒坦明®/Staquis®,规格:每克本品含20mg克立硼罗(2%),Pharmacia and Upjohn Company LLC)在健康受试者中的药代动力学行为,评价两种制剂的生物等效性。观察受试制剂和参比制剂(商品名:舒坦明®/Staquis®)在健康受试者中的安全性。
[Translation] The pharmacokinetic behavior of the single-use crisaborole ointment test formulation (Specification: 20 mg crisaborole (2%) per gram of this product, provided by Jiangsu Coast Pharmaceutical Co., Ltd.) and the reference formulation (trade name: Sutanming®/Staquis®, Specification: 20 mg crisaborole (2%) per gram of this product, Pharmacia and Upjohn Company LLC) in healthy subjects was studied to evaluate the bioequivalence of the two formulations. The safety of the test formulation and the reference formulation (trade name: Sutanming®/Staquis®) in healthy subjects was observed.
/ CompletedNot Applicable 阿瑞匹坦胶囊在健康受试者中空腹和餐后状态下随机、开放、两周期、双交叉生物等效性临床试验
[Translation] A randomized, open-label, two-period, double-crossover bioequivalence clinical trial of aprepitant capsules in healthy subjects under fasting and fed conditions
主要目的是研究空腹和餐后状态下,单次口服阿瑞匹坦胶囊受试制剂(规格:125mg,生产厂家:江苏海岸药业有限公司)与参比制剂(商品名:意美,规格:125mg,持证商:Merck Sharp & Dohme Ltd.)在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。次要目的是观察受试制剂和参比制剂(商品名:意美)在健康受试者中的安全性。
[Translation] The primary objective was to study the pharmacokinetic behavior of aprepitant capsules (specification: 125 mg, manufacturer: Jiangsu Coast Pharmaceutical Co., Ltd.) and reference preparation (trade name: Yimei, specification: 125 mg, licensee: Merck Sharp & Dohme Ltd.) in healthy subjects after a single oral administration under fasting and postprandial conditions, and to evaluate the bioequivalence of the two preparations. The secondary objective was to observe the safety of the test preparation and reference preparation (trade name: Yimei) in healthy subjects.
100 Clinical Results associated with Jiangsu COAST PHARMACEUTICAL CO., LTD
0 Patents (Medical) associated with Jiangsu COAST PHARMACEUTICAL CO., LTD
100 Deals associated with Jiangsu COAST PHARMACEUTICAL CO., LTD
100 Translational Medicine associated with Jiangsu COAST PHARMACEUTICAL CO., LTD