头孢地尼颗粒在健康受试者中随机、开放、单剂量、两制剂、两序列、两周期交叉空腹/餐后状态下的生物等效性试验
[Translation] Bioequivalence study of cefdinir granules in healthy subjects under randomized, open, single dose, two preparations, two sequences, two cycles cross fasting/fed states
主要研究目的:健康受试者空腹/餐后状态下,口服单剂量头孢地尼颗粒(受试制剂T,成都赛捷医药科技有限公司持有,四川赛卓药业股份有限公司生产,规格:50mg)与头孢地尼细粒剂(参比制剂R,LTLファーマ株式会社生产,商品名:Cefzon®,规格:50mg/0.5g)后,考察空腹和餐后条件下受试制剂与参比制剂的吸收速度和吸收程度,评价受试制剂与参比制剂是否具有生物等效性。
次要研究目的:观察受试制剂头孢地尼颗粒和参比制剂头孢地尼细粒剂(Cefzon®)在健康受试者中的安全性。
[Translation] The main purpose of the study: Healthy subjects were given a single dose of cefdinir granules orally (test preparation T, held by Chengdu Sage Pharmaceutical Technology Co., Ltd., produced by Sichuan Saizhuo Pharmaceutical Co., Ltd., under fasting/after meals, specifications: 50mg) and cefdinir fine granules (reference preparation R, produced by LTL Pharma Co., Ltd., trade name: Cefzon®, specification: 50mg/0.5g), investigate the test preparation and the reference preparation under fasting and postprandial conditions The absorption rate and degree of absorption, to evaluate whether the test preparation and the reference preparation have bioequivalence.
Secondary research purpose: To observe the safety of the test preparation Cefdinir Granules and the reference preparation Cefdinir Fine Granules (Cefzon®) in healthy subjects.
100 Clinical Results associated with Chengdu Saijie Pharmaceutical Technology Co., Ltd
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