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말레인산 암로디핀 정 5 mg과 베실산 암로디핀 정 5 mg의 약동학 특성 및 안전성 비교
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  • 말레인산 암로디핀 정 5 mg과 베실산 암로디핀 정 5 mg의 약동학 특성 및 안전성 비교
저자명
최희연,김재우,임형석,조상헌,김종률,최상민,정진아,임종래,배균섭,Choi. Hee-Youn,Kim. Jae-Woo,Lim. Hyeong-Seok,Cho. Sang-Heon,Ghim. Jong-Lyul,Choe. Sang-Min,J
간행물명
臨床藥理學會誌= The journal of Korean Society for Clinical Pharmacology and Therapeutics
권/호정보
2012년|20권 1호|pp.42-50 (9 pages)
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대한임상약리학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

Background: Amlodipine is a third-generation dihydropyridine calcium channel blocker for treating hypertension. Though marketed primarily as a besylate salt, there have been some efforts to find other comparable salts. Among them, maleate is the salt that has been considered favorable for many drugs. The aim of this study was to compare the pharmacokinetics, as well as safety and tolerability of amlodipine maleate with amlodipine besylate. Methods: This study was open, randomized, two-period crossover design investigated in twelve healthy male volunteers over a 144 h period after administrating two forms of amlodipine 5 mg, respectively. Each period was separated with 2 weeks. Plasma concentrations of amlodipine were determined by liquid chromatography-tandem mass spectrometry. Safety profiles were assessed by vital signs, physical examinations, electrocardiograms, laboratory testing and adverse events monitoring. Results: All subjects were completed this study. Geometric mean ratios (GMRs) of amlodipine maleate/amlodipine besylate of $C_{max}$ and $AUC_{last}$ for amlodipine were 0.92 (90% confidence interval, 0.81 ~ 1.05) and 1.05 (0.96 ~ 1.16), respectively. No serious adverse events were reported, and no clinically relevant changes were observed in safety profiles during this trial. Conclusion: Pharmacokinetics, tolerability and the safety were comparable between amlodipine maleate and amlodipine besylate in healthy individuals.