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서지반출
아디핀산 암로디핀 및 베실산 암로디핀의 약동학/약력학적 특성에 관한 비교 연구
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  • 아디핀산 암로디핀 및 베실산 암로디핀의 약동학/약력학적 특성에 관한 비교 연구
저자명
전지영,김정렬,정재용,오달석,조주연,유경상,신상구,장인진,Jeon. Ji-Young,Kim. Jung-Ryul,Chung. Jae-Yong,Oh. Dal-Seok,Cho. Joo-Youn,Yu. Kyung-Sang,Shin. Sa
간행물명
臨床藥理學會誌= The journal of Korean Society for Clinical Pharmacology and Therapeutics
권/호정보
2006년|14권 2호|pp.106-115 (10 pages)
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대한임상약리학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

Background: Amlodipine is a dihydropyridine calcium antagonist used for the treatment of hypertension and angina. Amlodipine adipate is a newly developed salt formulation of amlodipine. The purpose of this study was to compare the pharmacokinetic and pharmacodynamic characteristics of amlodipine adipate with those of conventional amlodipine besylate in healthy subjects. Methods: The study was conducted as a single blinded, block dose randomized, two-way crossover design. Twenty-four subjects were enrolled, twelve subjects each for the 5 mg dose group and the 10 mg dose group. Subjects were administered single oral dose of amlodipine adipate and amlodipine besylate, in a randomized sequence, with two weeks washout period between the two treatments. Serial blood samples were collected till 120 hours after drug administration. Plasma concentrations of amlodipine were analyzed by liquid chromatography tandem mass spectrometry. Individual pharmacokinetic parameters were calculated by noncompartmental methods and the pharmacokinetic parameters were analyzed by analysis of variance. Ambulatory blood pressure and computerized impedance cardiography were measured till 24 hours after drug administration. The pharmacodynamic parameters were analyzed by repeated-measures analysis of variance. Results: In the 5 mg dose group, the ratios of $AUC_{last}$ and $C_{max}$ of amlodipine adipate to amlodipine besylate were 0.93 and 0.89, respectively. In the 10 mg dose group, the ratios of $AUC_{last}$ and $C_{max}$ of amlodipine adipate to amlodipine besylate were 1.01 and 1.09, respectively. Regarding pharmacodynamic results, there were no significant differences in systolic blood pressure, diastolic blood pressure, pulse rate, or in change of total peripheral resistance between amlodipine adipate and amlodipine besylate at doses of both 5 mg and 10 mg. Conclusions: We concluded that amlodipine adipate and amlodipine besylate showed similar pharmacokinetic and pharmacodynamic characteristics.