/ CompletedNot Applicable 他达拉非片在健康男性受试者中的单剂量、随机、开放、交叉、两周期空腹和餐后人体生物等效性试验
[Translation] A single-dose, randomized, open-label, crossover, two-period fasting and fed bioequivalence study of tadalafil tablets in healthy male subjects
主要目的:以贵州圣济堂制药有限公司的他达拉非片(规格:20mg)为受试制剂,以Eli Lilly Nederland B.V.(礼来制药公司)的他达拉非片(规格:20mg)为参比制剂,按生物等效性试验的有关规定,考察两制剂在健康人体内的生物等效性。次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: To investigate the bioequivalence of the two preparations in healthy subjects, using the tadalafil tablets (specification: 20 mg) of Guizhou Shengjitang Pharmaceutical Co., Ltd. as the test preparation and the tadalafil tablets (specification: 20 mg) of Eli Lilly Nederland B.V. as the reference preparation according to the relevant provisions of the bioequivalence test. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.
/ CompletedNot Applicable 健康受试者空腹和餐后状态下口服盐酸多奈哌齐片后人体生物等效性试验
[Translation] Bioequivalence study of donepezil hydrochloride tablets in healthy subjects after fasting and fed state
主要目的:以贵州圣济堂制药有限公司生产的盐酸多奈哌齐片(规格:5 mg)为受试制剂,以卫材(中国)药业有限公司生产(规格:5 mg,商品名:安理申®)为参比制剂,进行空腹和餐后状态下人体生物等效性试验,评价受试制剂与参比制剂的生物等效性。
次要目的:观察空腹和餐后状态下,受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: To conduct a human bioequivalence study in the fasting and fed state using Donepezil Hydrochloride Tablets (Specification: 5 mg) produced by Guizhou Shengjitang Pharmaceutical Co., Ltd. as the test preparation and Aricept® produced by Eisai (China) Pharmaceutical Co., Ltd. as the reference preparation, and to evaluate the bioequivalence of the test preparation and the reference preparation.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects in the fasting and fed state.
/ CompletedNot Applicable 健康受试者餐后状态下口服
盐酸文拉法辛片后人体生物等效性试验
[Translation] Bioequivalence study of venlafaxine hydrochloride tablets in healthy subjects after oral administration in a fed state
主要目的:以贵州圣济堂制药有限公司生产的盐酸文拉法辛片(规格:50 mg(按C17H27NO2计))为受试制剂,以TEVA Czech Industries,s.r.o生产的盐酸文拉法辛片(规格:50 mg(按C17H27NO2计))为参比制剂,进行餐后状态下人体生物等效性试验,评价受试制剂与参比制剂的生物等效性。
次要目的:观察餐后状态下,受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: To conduct a human bioequivalence study in the fed state using venlafaxine hydrochloride tablets (specification: 50 mg (calculated as C17H27NO2)) produced by Guizhou Shengjitang Pharmaceutical Co., Ltd. as the test preparation and venlafaxine hydrochloride tablets (specification: 50 mg (calculated as C17H27NO2)) produced by TEVA Czech Industries, s.r.o. as the reference preparation, and evaluate the bioequivalence of the test preparation and the reference preparation.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects in the fed state.
100 Clinical Results associated with Guizhou Shengjitang Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Guizhou Shengjitang Pharmaceutical Co., Ltd.
100 Deals associated with Guizhou Shengjitang Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Guizhou Shengjitang Pharmaceutical Co., Ltd.