title: Population Pharmacokinetics of Lithium Carbonate in Young Male Healthy Chinese Volunteers.
abstract: 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 (Q/F) 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.
authors.affiliation: Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
authors.forename: W
authors.initials: W
authors.lastname: Yu
authors.affiliation: Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
authors.forename: X
authors.initials: X
authors.lastname: Sun
authors.affiliation: Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
authors.forename: Y
authors.initials: Y
authors.lastname: Li
authors.affiliation: Department of Pharmacometrics, Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
authors.forename: M
authors.initials: M
authors.lastname: Li
authors.affiliation: Department of Pharmacometrics, Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
authors.forename: K
authors.initials: K
authors.lastname: Wang
authors.affiliation: Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
authors.forename: H
authors.initials: H
authors.lastname: Li
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000097:blood / Q000493:pharmacokinetics*; D044466:Asian People; D003198:Computer Simulation; D018592:Cross-Over Studies; D064368:Healthy Volunteers; D006801:Humans; D016651:Lithium Carbonate / Q000097:blood / Q000493:pharmacokinetics*; D008297:Male; D008954:Models, Biological; D017711:Nonlinear Dynamics; D010599:Pharmacokinetics; D015203:Reproducibility of Results; D055815:Young Adult
chemical_list: D000928:Antidepressive Agents; D016651:Lithium Carbonate