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Comparison of Pharmacokinetics and Safety of a Fixed-dose Combination of Rosuvastatin and Ezetimibe Versus Separate Tablets in Healthy Subjects

Authors
 Kyoung Lok Min  ;  Min Soo Park  ;  Jina Jung  ;  Min Jung Chang  ;  Choon Ok Kim 
Citation
 Clinical Therapeutics, Vol.39(9) : 1799-1810, 2017 
Journal Title
 Clinical Therapeutics 
ISSN
 0149-2918 
Issue Date
2017
MeSH
Adult ; Anticholesteremic Agents/administration & dosage ; Anticholesteremic Agents/adverse effects* ; Anticholesteremic Agents/pharmacokinetics* ; Area Under Curve ; Asian Continental Ancestry Group ; Cross-Over Studies ; Drug Combinations ; Ezetimibe/administration & dosage ; Ezetimibe/adverse effects* ; Ezetimibe/pharmacokinetics* ; Healthy Volunteers ; Humans ; Male ; Middle Aged ; Rosuvastatin Calcium/administration & dosage ; Rosuvastatin Calcium/adverse effects* ; Rosuvastatin Calcium/pharmacokinetics* ; Tablets ; Young Adult
Keywords
ezetimibe ; fixed-dose combination ; pharmacokinetics ; rosuvastatin
Abstract
PURPOSE: Rosuvastatin and ezetimibe are concomitantly used for dyslipidemia treatment. Compared with separate tablets, fixed-dose combination (FDC) tablets of rosuvastatin/ezetimibe could increase patient compliance. The aim of this study was to compare the pharmacokinetic (PK) profiles of an FDC tablet of rosuvastatin/ezetimibe and co-administration of rosuvastatin and ezetimibe as separate tablets in healthy Korean volunteers. METHODS: This trial was a randomized, open-label, single-dose, 2-way crossover study. The healthy subjects received an FDC tablet of rosuvastatin 20 mg/ezetimibe 10 mg (test) or co-administration of rosuvastatin 20 mg and ezetimibe 10 mg (reference) in each period (periods 1 and 2), with a 14-day washout period. The blood samples for PK analysis were collected predose and up to 96 hours after administration, and safety was assessed throughout the study. FINDINGS: Sixty-four healthy Korean subjects were enrolled, and 57 subjects completed the study. All subjects were men and mean age was 28.52 ± 5.93. The geometric least squares mean ratios (test/reference) and 90% CIs of Cmax and AUC0-last were 101.54% (94.03-109.65) and 97.71% (91.86-103.93) for rosuvastatin, 108.93% (98.55-120.40) and 102.90% (96.72-109.47) for free ezetimibe, and 106.74% (98.18-116.05) and 104.24 % (99.53-109.17) for total ezetimibe. Twenty-four adverse events (AEs) were reported in 22 subjects. Three cases were related to the study drugs; 2 cases were mild, and 1 case was severe. However, all AEs were resolved without any sequelae. In addition, there were no serious AEs throughout the study. IMPLICATIONS: The FDC tablet of rosuvastatin/ezetimibe was well tolerated and resulted in comparable systemic exposure with co-administration of rosuvastatin and ezetimibe. ClinicalTrials.gov identifier: NCT02941848.
Full Text
https://www.sciencedirect.com/science/article/pii/S0149291817308275
DOI
10.1016/j.clinthera.2017.07.038
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아청소년과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Choon Ok(김춘옥) ORCID logo https://orcid.org/0000-0002-2319-1108
Park, Min Soo(박민수) ORCID logo https://orcid.org/0000-0002-4395-9938
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URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/161054
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