Population Pharmacokinetic Analysis of Valsartan in Healthy Chinese Subjects.

Haiyun Yang, Ruomei Gao, Xingfang Ji, Zhipeng Wang, Wen Qiu

Clinical pharmacology in drug development 2023 Mar

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The study was conducted to establish a population pharmacokinetic (PPK) model of valsartan in Chinese healthy subjects and investigate potential covariate impacts on the pharmacokinetics (PK) parameters. Data from a bioequivalence study with 78 Chinese healthy subjects were retrospectively analyzed to develop a PPK model of valsartan. Phoenix NLME 8.1 was used to build a PPK model and quantify the effects of covariates, such as demographic data and biochemical, on the PK parameters of valsartan. For the healthy Chinese population, valsartan conformed to the two-compartment model with an absorption lag time. In the final PPK model, food affected the absorption rate constant, while aspartate aminotransferase, alanine aminotransferase, and creatinine affected the clearance of the central compartment. The final PPK model was verified to be reproducible, and it can be used to evaluate the PK parameters. This is the first research describing the PPK profile of valsartan in healthy Chinese subjects, and it is expected to provide relevant PK parameters for further study of valsartan. © 2022 The Authors. Clinical Pharmacology in Drug Development published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology.

Citation

Haiyun Yang, Ruomei Gao, Xingfang Ji, Zhipeng Wang, Wen Qiu. Population Pharmacokinetic Analysis of Valsartan in Healthy Chinese Subjects. Clinical pharmacology in drug development. 2023 Mar;12(3):249-256