Clinical Trial: PBPK Modeling and Clinical Validation of Mirtazapine in the Vietnamese Population: Integration of Bioequivalence Data and Evaluation of the Impact of Physiological and Metabolic Variability

U.S., Nov. 14 -- ClinicalTrials.gov registry received information related to the study (NCT07936565) titled 'PBPK Modeling and Clinical Validation of Mirtazapine in the Vietnamese Population: Integration of Bioequivalence Data and Evaluation of the Impact of Physiological and Metabolic Variability' on Nov. 07.

Brief Summary: This study aims to develop and clinically validate a physiologically based pharmacokinetic (PBPK) model of mirtazapine in the Vietnamese population and to evaluate the influence of physiological characteristics, metabolic variability, and CYP2D6 genetic polymorphisms on drug exposure.

The PBPK model will be developed using published physicochemical, metabolic, and clinical pharmacokinetic data, incorporating Vietnames...