Study on Bioequivalence of Cefdinir Capsules in Chinese Healthy Volunteers

VernacularTitle:头孢地尼胶囊在健康人体的生物等效性研究
Author: Fen CHEN ; Chaoran ZHU ; Xuejia ZHAI ; Xia FENG ; Guiping DENG ; Qing GUO ; Lifen JIANG ; Yongning LYU
Publication Type:Journal Article
Keywords: Cefdinir capsules; Liquid chromatography-tandem mass spectrometry; Pharmacokinetics; Bioequivalence
From: Herald of Medicine 2015;(10):1288-1291
CountryChina
Language:Chinese
Abstract: Objective To evaluate postprandial pharmacokinetics and bioequivalence of two preparations of cefdinir capsules in Chinese healthy volunteers. Methods In a two-way cross-over study, 24 healthy male volunteers were divided into two groups randomly and a single dose of cefdinir capsules of test and reference preparation were administered orally, respectively.The concentration in plasma was determined by LC-MS/MS. Pharmacokinetic parameters and bioequivalence were calculated and evaluated by DAS. Results The main pharmacokinetic parameters of test and reference were as follows: AUCt (4.35±1.09) μg??h??mL-1 and (4.12±1.22) μg??h??mL-1, AUC0-∞(4.53±1.12) and (4.53±1.73) μg??h??mL-1, t1/2 (1.74±0.29) h and (2.13±1.65) h, tmax(4.44±0.86) h and (4.54 ±1.16) h, Cmax(900±250) ng??mL-1 and (876±269) ng??mL-1 . Conclusion The test and reference preparation of cefdinir capsules are bioequivalent.