/ CompletedNot Applicable 一项随机、开放、单剂量、两周期、双交叉、空腹和餐后给药临床研究,评价非诺贝特胶囊与Lipanthyl在中国健康成年参与者中的生物等效性
[Translation] A randomized, open-label, single-dose, two-period, double-crossover, fasting and fed administration clinical study to evaluate the bioequivalence of fenofibrate capsules and lipanthyl in healthy Chinese adult participants
主要目的:
以广州市陌希生物技术有限公司持有的非诺贝特胶囊(0.2g)为受试制剂,以Abbott Laboratories Limit ED持有的非诺贝特胶囊(商品名:Lipanthyl,规格:0.2g)为参比制剂,进行生物等效性试验,比较两种制剂在空腹和餐后条件下单次给药的生物等效性。
次要目的:
评估单剂量口服受试制剂(非诺贝特胶囊,T)和参比制剂(Lipanthyl,R)在中国健康成年参与者中的安全性。
[Translation] Primary objective:
The bioequivalence study was conducted using fenofibrate capsules (0.2 g) held by Guangzhou Moxi Biotechnology Co., Ltd. as the test preparation and fenofibrate capsules (trade name: Lipanthyl, specification: 0.2 g) held by Abbott Laboratories Limit ED as the reference preparation to compare the bioequivalence of the two preparations under fasting and postprandial conditions.
Secondary objective:
To evaluate the safety of a single oral dose of the test preparation (fenofibrate capsules, T) and the reference preparation (Lipanthyl, R) in healthy adult participants in China.
100 Clinical Results associated with Guangzhou Moxi Biotechnology Co., Ltd.
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100 Deals associated with Guangzhou Moxi Biotechnology Co., Ltd.
100 Translational Medicine associated with Guangzhou Moxi Biotechnology Co., Ltd.