Development of a population pharmacokinetic model to describe olmesartan medoxomil/hydrochlorothiazide (20/12.5 mg) FDC tablet in male healthy South Korean subjects
- Authors
- Chae, Jung-Woo; Baek, In-hwan; Seo, Jeong-won; Jung, Sang-hoon; Back, Hyun-moon; Song, Byung-jeong; Lee, Byung-yo; Yun, Hwi-yeol; Kang, Wonku; Kwon, Kwang-il
- Issue Date
- Aug-2014
- Publisher
- DUSTRI-VERLAG DR KARL FEISTLE
- Keywords
- olmesartan medoxomil; hydrochlorothiazide; combination drug; nonlinear mixed effect modeling; population pharmacokinetic
- Citation
- INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS, v.52, no.8, pp 676 - 683
- Pages
- 8
- Journal Title
- INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
- Volume
- 52
- Number
- 8
- Start Page
- 676
- End Page
- 683
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/11996
- DOI
- 10.5414/CP202046
- ISSN
- 0946-1965
- Abstract
- Aim: The objective of the present study was to develop population pharmacokinetic models for olmesartan medoxomil and hydrochlorothiazide and to investigate the influence of demographic factors on these population pharmacokinetics. Methods: Plasma concentrations of olmesartan medoxomil and hydrochlorothiazide were measured in 41 healthy volunteers enrolled in our bioequivalence study by LC-MS/MS following oral administration of an olmesartan medoxomil/hydrochlorothiazide (20/12.5 mg) fixed-dose combination tablet. This data and covariates were subjected to nonlinear mixed-effect modeling analysis using the NONMEM software. Evaluation featured a visual predicted check and bootstrapping. Results: The distributions of olmesartan medoxomil and hydrochlorothiazide were best fitted using a two-compartment model with no lag time and first-order elimination. When analyzing hydrochlorothiazide kinetics, we found that TCHO and CL/F were correlated, while HB and K-a influenced olmesartan medoxomil modeling. All evaluations indicated that the pharmacokinetic profiles of olmesartan medoxomil and hydrochlorothiazide were adequately described using our PPK model. Conclusions: This study indicates that demographic factors influence the inter-individual variability in the disposition of the combination drug, and it might be more useful to apply it to the PK of olmesartan medoxomil/hydrochlorothiazide (20/12.5 mg) FDC tablets administered to patients with hypertension.
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