NDLI: Development of a population pharmacokinetic model to describe olmesartan medoxomil/ hydrochlorothiazide (20/12.5 mg) FDC tablet in male healthy South Korean subjects.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	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
Spatial Coverage	Republic of Korea
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 Ka 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. *These two authors contributed equally to this work.
File Format	HTM / HTML
ISSN	09461965
Issue Number	8
Volume Number	52
Journal	Int. Journal of Clinical Pharmacology and Therapeutics
Language	English
Publisher	Dustri-Verlag
Publisher Date	2014-08-01
Publisher Place	Germany
Access Restriction	Subscribed
Subject Keyword	Discipline Pharmacology Antihypertensive Agents Pharmacokinetics Hydrochlorothiazide Imidazoles Models, Biological Tetrazoles Administration, Oral Adult Administration & Dosage Chromatography, Liquid Methods Cross-over Studies Drug Combinations Humans Male Nonlinear Dynamics Olmesartan Medoxomil Republic Of Korea Tablets Tandem Mass Spectrometry Therapeutic Equivalency Young Adult Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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