Pharmacokinetcs of single dose cefepime injection in Chinese Han, Mongolia, Korean, Uigur, and Hui healthy volunteers
- Author:
Tao GUO
1
Author Information
1. Department of Pharmacy
- Publication Type:Journal Article
- Keywords:
Cefepime;
Chinese Han;
Chinese Hui;
Chinese Korean;
Chinese Mongolia;
Chinese Uigur;
HPLC;
Pharmacokinetics
- From:
Chinese Pharmaceutical Journal
2012;47(14):1134-1138
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE: To investigate and compare the pharmacokinetics of cefepime in healthy volunteers of different Chinese nationalities (Han, Mongolia, Uigur, Korea, and Hui) and different genders, thus to provide instruction and help for using cefepime safely, rationaly and effectively in both ordinary clinic and remedy of battle wound. METHODS: A single dose of 1.0 g cefepime was given by intravenous infusion under fasting condition to ten healthy volunteers (five males and five females) of each Chinese nationality. Plasma samples were obtained before dosing and at various predetermined time points after the dosing, and the plasma concentrations were determined by a validated HPLC-UV method. The pharmacokinetic parameters were calculated by DAS2.0 software and were compared by SPSS11.5 software. RESULTS: The PK parameters of cefepime in Han, Mongolia, Uigur, Korea and Hui nationalities after a single intravenous administration of 1.0 g were as follows: t1/2β (1.97 ± 0.20), (2.10 ± 0.33), (2.06 ± 0.33), (2.40 ± 0.65), and (1.94 ± 0.24) h; AUC0-β (139.69 ± 23.78), (153.92 ± 22.79), (165.58 ± 24.49), (142.11 ± 29.77), and (132.78 ± 23.79) mg · h · L-1;ρmax(68.75 ± 10.41), (78.22 ± 13.87), (83.19 ± 10.31), (73.82 ± 9.59), and (62.91 ± 10.09) mg · L-1 , respectively. The PK parameters of cefepime in 25 male volunteers and 25 female volunteers after a single intravenous administration of 1.0 g were as follows: t1/2β (2.06 ± 0.54) and (2.13 ± 0.44)h; AUC0-β (134.06 ± 22.33) and (158.68 ± 24.85)mg · h · L-1;ρmax (66.94 ± 9.14) and (78.95 ± 12.71)mg · L-1, respectively. Results of ANOVA and Kruskal-Wallis rank test showed that there were no significant differences in the PK parameters Vd, CL, InAUC, and t1/2β of different nationalities and in Vd and t1/2β of different genders, but there were significant differences in lnρmax of different nationalities and CL, InAUC, and lnρmax of different genders. Then, it was found there was high linear correlation( P < 0.01) between body weight and CL, InAUC and lnρmax. The differences of the above PK parameters became insignificant after normalization by body weight. CONCLUSION: When cefepime is given in doses based on body weight, its pharmacokinetics has no significant differences among five nationalities and between genders. Copyright 2012 by the Chinese Pharmaceutical Association.
