Population Pharmacokinetics of Paliperidone Palmitate (Once-Monthly Formulation) in Japanese, Korean, and Taiwanese Patients With Schizophrenia.

ABSTRACT: The paliperidone pharmacokinetics after intramuscular administration of once-monthly paliperidone palmitate in Japanese patients were studied in 3 phase 1 studies and in 2 phase 3 studies performed in Japan, Korea, and Taiwan. These data (Japanese, n = 509; Korean, n = 31; Taiwanese, n = 47) were used to describe the paliperidone palmitate pharmacokinetics in Japanese, to compare with non-Japanese, and to validate the historical population pharmacokinetic (Pop-PK) model for paliperidone palmitate, developed using data from studies in patients with schizophrenia outside Japan. The final historical Pop-PK model, including all significant patient covariates of Japanese studies, was used to simulate paliperidone plasma concentration-time data using nonlinear mixed effects, followed by comparis

SUBMITTER: Shimizu H 

PROVIDER: S-EPMC7028061 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature