Earticle

초록

영어

Bioequivalence(BE) test of commercially available sustained release tablets of diltiazem hydrochloride(DTZ) was performed to give some guidelines to BE test in korea in case of which drugs with low oral bioavaiiability(BA) due to substantial first-pass hepatic loss form pharmacologically active metabolites. In such cases, the pharmacologic activity after oral administration is greater than anticipated from BA data, based on chemical assay of drug alone. Therefore, this paper explores the use and meaning of area under the plasma concentration-time(AUC) data of parent and its metabolites to access BA if sustained release tablets. Normal healthy male volunteers(n=14) were randomly divided into 2 groups, and sustained release reference and test tablets of DTZ-30mg were given orally by balanced two-period cross-over dosing schedule. The plasma concentration of DTZ and and its active metabolite, desacetyldiitiazem(DAD), were determined by high performance liquid chromatography, and, obtained. Analysis of varlance(ANOVA) showed that passed the standard of BE test of korea, but was not satisfied from the standpoint of power. On the other hand, may be more avaliable than from the standpoint of statistics and pharmacologic equivalence.

저자

• 이용복 [ Lee, Young-Bok | 전남대학교 병원약제부(Department of Pharmacy, Chonnam National University Hospital) ]
• 고익배 [ Koh, Ik-Bae | 전남대학교 약학대학(College of Pharmacy, Chonnam National University) ]
• 서세민 [ Seo, Se-Min | 한일약품공업 주식회사(Hanil Pharmaceutical Ind Co., Ltd.) ]
• 윤형중 [ Yoon, Heong-Tung | 한일약품공업 주식회사(Hanil Pharmaceutical Ind Co., Ltd.) ]

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  한국임상약학회지 [Korean Journal of Clinical Pharmacy]

• 간기

  계간

• pISSN

  1226-6051

• 수록기간

  1991~2026

• 등재여부

  KCI 등재

• 십진분류

  KDC 518 DDC 615