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[Translation] Bioequivalence study of fenofibrate tablets (III) in humans under fasting and fed conditions
研究健康研究参与者在空腹和餐后条件下,单次口服由深圳格莱恩生物医药科技有限公司提供的非诺贝特片(III)(受试制剂,规格:0.16g)与相同条件下单次口服由Abbott Laboratories(Singapore)Private Limited持证的非诺贝特片(III)(参比制剂,商品名:力平之®,规格:0.16g)的药动学特征,评价两制剂间的生物等效性,为受试制剂的注册申请提供依据。
[Translation] To investigate the pharmacokinetic characteristics of a single oral administration of fenofibrate tablets (III) (test preparation, strength: 0.16 g) provided by Shenzhen Green Biopharmaceutical Technology Co., Ltd. to healthy study participants under fasting and postprandial conditions, compared with a single oral administration of fenofibrate tablets (III) (reference preparation, trade name: Lipingzhi®, strength: 0.16 g) certified by Abbott Laboratories (Singapore) Private Limited under the same conditions, to evaluate the bioequivalence between the two preparations and provide a basis for the registration application of the test preparation.
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