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논문 리스트

2008
딜라트렌 정 12.5밀리그람(카르베딜롤 12.5밀리그람)에 대한 카딜란 정 12.5밀리그람의 생물학적동등성 Bioequivalence of Cadilan Tablet 12.5 mg to DilatrendR Tablet 12.5 mg (Carvedilol 12.5 mg)
한국약제학회
논문정보
Publisher
약제학회지
Issue Date
2008-12-20
Keywords
-
Citation
-
Source
-
Journal Title
-
Volume
38
Number
6
Start Page
413
End Page
419
DOI
ISSN
02592347
Abstract
Carvedilol, is a nonselective β-blocking agent and it also has vasodilating properties that are attributed mainly to its blocking activity at α1-receptors. The purpose of the present study was to evaluate the bioequivalence of two carvedilol tablets, DilatrendR tablet 12.5 mg (Chong Kun Dang Pharmaceutical Co., Ltd.) and Cadilan tablet 12.5 mg (KyungDong Pharmaceutical. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of carvedilol from the two carvedilol formulations in vitro was tested using KP VIII Apparatus II method with pH 4.5 dissolution medium. Thirty two healthy male subjects, 25.00±3.09 years in age and 70.71±11.35 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After a single tablet containing 12.5 mg as carvedilol was orally administered, blood samples were taken at predetermined time intervals and the concentrations of carvedilol in serum were determined using HPLC wi

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