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| Population pharmacokinetics study of Omeprazole Enteric-Coated Capsules in Chinese healthy subjects |
| ZHAO Zheng SONG Boli LIU Yunxin ZOU Jianjun ZHU Yubing |
| Department of Pharmacy, Nanjing First Hospital, Nanjing Medical University, Jiangsu Province, Nanjing 210006, China |
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Abstract Objective To establish population pharmacokinetics model of Omeprazole Enteric-Coated Capsules in Chinese healthy subjects, thus quantitatively evaluating the factors that could influence clinical pharmacokinetics of Omeprazole. Methods Twenty healthy male subjects recruited in Nanjing First Hospital from April 2016 to June 2016 were given 20 mg single dose of Omeprazole Enteric-Coated Capsules and plasma concentrations of the drug were determined by LC-MS/MS. CYP2C19 gene polymorphism was measured by polymerase chain reaction-restriction fragment length polymorphism method. The population pharmacokinetic model was established by nonlinear mixed effect model (NONMEM)program and estimated by bootstrap procedure. Results One-compartmen model of first-order elimination had fit for Omeprazole pharmacokinetics. Inter-individual variability was described by exponential model．The population typical values of CL/F,V/F and Ka were19.5L/h,16Land0.633/h. BUN had a significant influence on Ka. CYP2C19 phenotype showed significant effects on CL/F. The parameters estimated from bootstrap procedure were comparable to those from NONMEM. Conclusion The established population pharmacokinetics model can explain the individual pharmacokinetic variations of Omeprazole, which provides guidance for clinical personalized drug administration.
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