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To establish a population pharmacokinetic model of amoxicillin and clavulanate potassium tablets in healthy Chinese subjects under fasting condition.
Based on the previously confirmed bioequivalence results, this study retrospectively collected the plasma concentration data of 18 subjects who received the test preparation and 17 subjects who received the reference preparation. The population pharmacokinetic model of amoxicillin was constructed using Phoenix NLME software. The effects of covariates such as gender, age, albumin, serum creatinine, creatine kinase, fasting blood glucose, and total cholesterol on pharmacokinetics were evaluated by forward inclusion and backward elimination methods. Model validation included goodness-of-fit plots, bootstrap method, and visual predictive check (VPC).
The population pharmacokinetic model of amoxicillin in healthy subjects conformed to a two-compartment model with first-order elimination kinetics and lag time, which could well describe the data. Serum creatinine and body mass index (BMI) were significant covariates. The parameters of the final model were as follows: central volume of distribution (V)=51.56 L, peripheral volume of distribution (V2)=7.65 L; clearance (CL)=39.99 L·h-1, intercompartmental clearance (CL2)=1.78 L·h-1, absorption rate constant (Ka)=1.45 h-1. Serum creatinine had an impact on CL2 and Ka, while BMI affected V.
The two-compartment model with first-order elimination kinetics and lag time can better describe the in vivo absorption characteristics of amoxicillin after oral administration of amoxicillin and clavulanate potassium tablets in healthy subjects.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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