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• W1976280369 abstract "1 Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, Seoul, Korea, University of Ulsan College of Medicine, School of Military Medicine, The First Republic of Korea Army, Department of Clinical Pharmacology and Therapeutics, Inje University Pusan Paik Hospital, Pusan, Korea, 5 Division of Clinical Pharmacology, Clinical Trials Center, Pusan National University Hospital, Division of Clinical Pharmacology, Clinical Trial Center, Samsung Medical Center, Technical research center, CKD research institute, Chong Kun Dang Pharmaceutical Co, Ltd 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 Cmax and AUClast 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." @default.
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• W1976280369 date "2012-01-01" @default.
• W1976280369 modified "2023-10-17" @default.
• W1976280369 title "Comparison of Pharmacokinetic Characteristics and the Safety between Amlodipine Maleate Tablet 5 mg and Amlodipine Besylate Tablet 5 mg" @default.
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• W1976280369 doi "https://doi.org/10.12793/jkscpt.2012.20.1.42" @default.
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