Abstract:
BACKGROUND AND OBJECTIVES:Bilastine is a novel second-generation antihistamine for the symptomatic treatment of allergic rhinitis and urticaria. The objective of this study was to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of bilastine following single and multiple oral doses in healthy Japanese subjects. The pharmacokinetic and pharmacodynamic profiles were compared with those reported in Caucasian subjects. METHODS:In a single-blind, randomized, placebo-controlled, parallel-group, single- and multiple-ascending dose study, bilastine tablets were administered at single doses of 10, 20, and 50 mg (Part I), and once daily for 14 days at 20 and 50 mg (Part II). RESULTS:After single oral doses, maximum plasma concentrations (C max) were reached at 1.0-1.5 h postdose. Plasma exposure [C max and area under the plasma concentration-time curve (AUC)] increased dose-proportionally at single doses of 10-50 mg. In repeated-dose administration, no remarkable differences were observed between Day 1 and Day 14 for C max or AUC. For inhibitory effects on wheal and flare response, bilastine 20 and 50 mg showed significant inhibition from 1.5 h after administration as compared with placebo, and the significant effect persisted for 24 h after administration. The rates of adverse events (AEs) were comparable between bilastine and placebo in both Part I and Part II. In addition, no dose- or administration period-dependent tendency of increase in rate of AEs or worsening of severity was observed. CONCLUSION:Bilastine exhibits similar single- and multiple-dose pharmacokinetic and pharmacodynamic characteristics in healthy Japanese subjects compared with those observed in Caucasian subjects in previous studies.
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
Togawa M,Yamaya H,Rodríguez M,Nagashima Hdoi
10.1007/s40261-016-0447-2subject
Has Abstractpub_date
2016-12-01 00:00:00pages
1011-1021issue
12eissn
1173-2563issn
1179-1918pii
10.1007/s40261-016-0447-2journal_volume
36pub_type
杂志文章,随机对照试验abstract:OBJECTIVE:To evaluate the effectiveness and safety of amlodipine in two cohorts of hypertensive patients, one newly diagnosed and the other previously diagnosed but not controlled with drug therapy, and to assess the risk factors for the entire sample at the outset of the study. PATIENTS AND DESIGN:We designed a postm...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323120-00001
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The degree of cycle control achieved with a hormonal contraceptive method is an important determinant of its acceptance and continuation. This study set out to compare the cycle control and bleeding profile of drospirenone (DRSP) 3 mg/ethinylestradiol (EE) 20 μg in a 24-active pill/4-inert pill...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章,meta分析,多中心研究
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abstract:BACKGROUND:European guidelines do not recommend the use of carbamazepine, levetiracetam, phenobarbital, phenytoin, topiramate and valproic acid in patients taking direct oral anticoagulants (DOACs). Little is known regarding the clinical relevance of the interaction between DOACs and antiepileptic drugs. OBJECTIVES:To...
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doi:10.1007/s40261-020-00982-8
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journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章,多中心研究
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journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究
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更新日期:2018-01-01 00:00:00
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journal_title:Clinical drug investigation
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pub_type: 杂志文章
doi:10.1007/s40261-015-0295-5
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journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-013-0147-0
更新日期:2014-01-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-013-0158-x
更新日期:2014-01-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章
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abstract:OBJECTIVE:To characterise the pharmacokinetics of indinavir during different phases of the menstrual cycle in HIV-infected women. DESIGN:Open-label study. SETTING:The immunodeficiency clinic at Erie County Medical Center, Buffalo, New York. PATIENTS:Ten HIV-infected women were enrolled in the study. Eligibility crit...
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pub_type: 杂志文章
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journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/00044011-200626050-00004
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pub_type: 杂志文章,多中心研究
doi:10.1007/s40261-013-0092-y
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doi:10.2165/00044011-200828100-00002
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pub_type: 已发布勘误
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更新日期:2019-01-01 00:00:00
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pub_type: 杂志文章,随机对照试验
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pub_type: 杂志文章
doi:10.1007/s40261-020-00959-7
更新日期:2020-11-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章,多中心研究
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更新日期:2012-04-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章
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pub_type: 已发布勘误
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pub_type: 杂志文章
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journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章,多中心研究
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journal_title:Clinical drug investigation
pub_type: 杂志文章
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更新日期:2012-05-01 00:00:00