24名健康男性受试者单中心,随机,交叉口服尼扎替丁胶囊人体生物等效性试验
[Translation] A single-center, randomized, crossover human bioequivalence trial of oral nizatidine capsules in 24 healthy male subjects
通过分别观察健康成年男性在空腹或在进食高脂肪试验餐状态下单剂量交叉口服由汕头经济特区鮀滨制药厂提供的尼扎替丁胶囊试验制剂和参比制剂后,尼扎替丁的体内经时过程,估计其药代动力学参数,评价受试制剂的相对生物利用度,判断受试制剂与参比制剂是否具有人体生物等效性,指导临床用药。
[Translation] By observing the in vivo nizatidine test preparation and reference preparation of nizatidine capsules provided by Shantou Special Economic Zone Jibin Pharmaceutical Factory after single-dose cross-oral administration in healthy adult males on an empty stomach or a high-fat experimental meal, respectively. Over time, the pharmacokinetic parameters are estimated, the relative bioavailability of the test preparation is evaluated, and whether the test preparation and the reference preparation are bioequivalent to humans can be used to guide clinical medication.
100 Clinical Results associated with Shantou Special Economic Zone Yunbin Pharmaceutical Factory
0 Patents (Medical) associated with Shantou Special Economic Zone Yunbin Pharmaceutical Factory
100 Deals associated with Shantou Special Economic Zone Yunbin Pharmaceutical Factory
100 Translational Medicine associated with Shantou Special Economic Zone Yunbin Pharmaceutical Factory