Population pharmacokinetics of cefaclor in healthy Chinese adult male volunteers

Abstract

Abstract: AIM: To develop a population pharmacokinetic model of cefaclor in healthy volunteers and evalute the effect of individual factors on the pharmacokinetics of cefaclor. METHODS: A nonlinear mixed-effect modeling was developed to analyze the data of cefaclor bioequivalence studies in healthy volunteers and calculate the related parameters and inter- and intra variabilties. RESULTS: two-compartment model with first order absorption was fitted to the cefaclor concentration data. The population value of CL, V2, V3, K_A were 0.219 L/min, 35.9 L, 598 L, 0.042 min^-1, respectively. CL was found to be significantly related to the covariate of weight. CONCLUSION: The population pharmacokinetic model can be used to provide accurate individual pharmacokinetic parameters. CL was significantly influenced by the covariate of weight, which showed that it is better to administer drug according to the per kilogram of body weight in clinical practice.

Key words: Amlodipine, Healthy Volunteers, Population Pharmacokinetics

CLC Number:

R969

HUANG Ji-han, HUANG Xiao-hui, WANG Kun, LI Jun, ZHENG Qing-shan. Population pharmacokinetics of cefaclor in healthy Chinese adult male volunteers[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2012, 17(6): 659-665.

References

[1] Kammer RB. Cefaclor in management of streptococcal pharyngitis, otitis media, and skin infections[J]. Ann Otol Rhinol Laryngol Suppl, 1981, 90(3):79-81.
[2] ZeLuff B, Catchpole M, Lowe P, et al. Cefadroxil compared with cefaclor in the treatment of streptococcal pneumonia in adults[J]. Drugs, 1986, 32(3): 39-42.
[3] Dorow P. Safety and efficacy of cefixime versus cefaclor in respiratory tract infections[J]. J Chemother, 1989, 1(4):257-260.
[4] Sheiner LB, Beal SL. NONMEM users guide, part V[S]. University of California, San Francisco. 1998.
[5] Sheiner LB, Beal SL.Pharmacokinetic parameter estimates from several least squares procedures:superiority of extended least squares[J].J Pharmacokinet Biopharm, 1985,13(2):185-201.
[6] Sheiner LB. The population approach to pharmacokinetic data analysis: rationale and standard data analysis methods[J]. Drug Metabolism Reviews, 1984, 15(1):153-171.
[7] Mandema JW, Verotta D, Sheiner LB. Building population pharmacokinetic-pharmacodynamic models. I. Models for covariate effects[J]. J Pharmacokinet Biopharm, 1992,20:511-528.
[8] Ribbing J, Jonsson EN. Power, selection bias and predictive performance of the Population Pharmacokinetic Covariate Model[J]. J Pharmacokinet Pharmacodyn, 2004,31(2): 109-134.
[9] Ribbing J, Nyberg J, Caster O, et al.The lasso-a novel method for predictive covariate model building in nonlinear mixed effects models[J].J Pharmacokinet Pharmacodyn, 2007, 34(4): 485-517.
[10] Ribbing J, Hooker AC, Jonsson EN. Non-Bayesian knowledge propagation using model-based analysis of data from multiple clinical studies[J]. J Pharmacokinet Pharmacodyn, 2008, 35(1): 117-137.
[11] Ribbing J, Hamrén B, Svensson MK, et al.A model for glucose, insulin, and beta-cell dynamics in subjects with insulin resistance and patients with type 2 diabetes[J]. J Clin Pharmacol, 2010, 50(8):861-872.
[12] Efron B. Bootstrap methods: another Look at the Jackknife[J]. Ann Stat, 1979,7(1): 1-12.
[13] 盛玉成, 郑青山. 群体药代动力学及其在新药研究中的应用[J]. 中国临床药理学与治疗学, 2004, 9(12): 1333-1334.
[14] 黄晓晖,黄继汉, 李禄金, 等. 氨氯地平在中国健康志愿者体内的群体药动学研究[J]. 中国临床药理学与治疗学杂志, 2011,16(2): 1383-1390.

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