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Effect of food on the pharmacokinetics of darexaban, an oral direct factor Xa inhibitor, in healthy Japanese subjects.
MedLine Citation:
PMID:  23211396     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Background: Darexaban is a potent direct factor Xa (FXa) inhibitor developed for prophylaxis of venous and arterial thromboembolic disease. This drug is rapidly and extensively metabolized to darexaban glucuronide (YM-222714), which is a pharmacologically active metabolite. The potential effects of food on the harmacokinetics of darexaban glucuronide after darexaban administration were assessed in two studies. Methods: Both studies were conducted as open-label, two-way crossover studies. Healthy non-elderly Japanese male subjects received darexaban as a single 15 mg tablet (Study 1, n = 24) or a single 30 mg tablet (Study 2, n = 24). The geometric mean ratio (GMR) (fed/fasted) for AUClast and Cmax were evaluated as primary parameters. Results: GMR(fed/fasted) for AUClast emonstrated slight decreases as 0.797 (90% CI: 0.758 - 0.838) in Study 1 and 0.821 (90% CI: 0.752 - 0.896) in Study 2. For Cmax, the GMR was 0.908 (90%CI: 0.835 - 0.988) in Study 1 and 1.039 (90% CI: 0.953 - 1.131) in Study 2. There were no serious adverse events during the two studies. None was considered to be drug-related. Conclusion: These studies demonstrated that there was no clinically significant effect of food on the pharmacokinetics after administration of darexaban. We therefore conclude that darexaban can be administered without regard to food intake.
Authors:
Takeshi Kadokura; Yuta Taniuchi; Hiroshi Inoue; Masako Saito; Mioko Iwahana; Shunsuke Yamada; Akinori Urae; Mashio Nakamura
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-12-4
Journal Detail:
Title:  International journal of clinical pharmacology and therapeutics     Volume:  -     ISSN:  0946-1965     ISO Abbreviation:  Int J Clin Pharmacol Ther     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-5     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9423309     Medline TA:  Int J Clin Pharmacol Ther     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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