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KMID : 0391020130210020095
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Journal of Korean Society for Clinical Pharmacology and Therapeutics
2013 Volume.21 No. 2 p.95 ~ p.103
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Comparison of Pharmacokinetic Characteristics and Safety Between JW Amlodipine® Tablet 5 mg and Novarsc® Tablet 5 mg in Healthy Male Volunteers
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Kim Yo-Han
Lim Hyeong-Seok
Cho Sang-Heon
Ghim Jong-Lyul
Choe Sang-Min
Jung Jin-Ah
Bae Kyun-Seop
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Abstract
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Background: Amlodipine is a third-generation dihydropyridine calcium channel blocker, which has proven to be a useful drug against hypertension or angina.
Methods: This randomized, open-label, two-period, two-treatment, single-dose, crossover study was conducted in twenty healthy male volunteers. Subjects were administered 5 mg of the test or reference formulation. After 2-week washout period, the other formulation was administered. Blood samples were collected up to 144 hours after drug administration, and plasma amlodipine concentrations were determined by validated liquid chromatography-tandem mass spectrometry. Drug safety was assessed using measurement of vital signs, physical examinations, laboratory test, electrocardiograms, and adverse event monitoring.
Results: All subjects were completed this study. The geometric mean ratios of Cmax and AUClast were 1.078 (90 % CI, 0.968 ? 1.200) and 1.095 (90 % CI, 1.011 ? 1.186), respectively. There were no serious adverse events were reported by both formulations.
Conclusion: This study showed the test and reference formulations had similar pharmacokinetics and safety profiles.
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KEYWORD
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Amlodipine, Pharmacokinetics, Safety, Healthy volunteers
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