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Background: Modafinil is a psychostimulant used to treat excessive sleepiness. The aim of this study was to develop a population pharmacokinetic model of modafinil and its major metabolites in Chinese male adults and to identify covariates that predict variability in disposition. Methods: Eighty healthy volunteer subjects were randomized to 4 oral dose groups: 3 doses of 50 mg of modafinil, 3 doses of mg of modafinil, 2 doses of mg of modafinil plus 1 dose of placebo, or 3 doses of placebo each dose given 8 hourly. Blood samples were collected up to 58 hours post-first dose for plasma concentrations of modafinil and its metabolites. The population pharmacokinetic study was conducted using the nonlinear mixed-effects model software, NONMEM, and validated using the bootstrap, crossvalidation and visual predictive check approaches.

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