Aim: To investigate the population pharmacokinetics (PK) model of lithium carbonate in young male healthy Chinese subjects.
Methods: This study was conducted using a 2-period crossover design. 20 healthy male subjects received lithium carbonate tablets from 2 different Chinese pharmaceutical manufacturers. Plasma samples were obtained by blood sampling over 72 h in each period. Population PK analysis was performed using nonlinear mixed effects model (NONMEM) software. The final models were validated using bootstrap and visual predictive check (VPC) approaches.
Results: The final PK model was a two-compartment model. The population PK parameters, clearance (CL/F), apparent distribution volume of the central compartment (V2/F), inter-compartmental clearance (QJF) and apparent distribution volume of the peripheral compartment (V3/F), were 9.39 L/h, 10.4 L, 22.1 L/h, and 216 L, respectively.
Conclusion: Population PK models for lithium carbonate have been developed and considerable inter-subject variability was found in healthy young male Chinese subjects. It takes a long time to achieve the steady state in conventional therapy. This may provide guidelines for future use of lithium carbonate in China.
[1]Shanghai Jiao Tong Univ, Shanghai Mental Hlth Ctr, Sch Med, Shanghai 200030, Peoples R China.
[2]Shanghai Univ Tradit Chinese Med, Dept Pharmacometr, Ctr Drug Clin Res, 1200 Cailun Rd, Shanghai 201203, Peoples R China.
(8.0+极速模式)