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2013 (v.21 no.2)

The Journal of Korean Society for Clinical Pharmacology and Therapeutics

Korean Society for Clinical Pharmacology and Therapeutics
Semiannual
ISSN: 1225-5467

  • Comparison of Pharmacokinetic Characteristics and Safety Between JW Amlodipine® Tablet 5 mg and Novarsc® Tablet 5 mg in Healthy Male Volunteers

    Yo Han Kim, Hyeong-Seok Lim, Sang-Heon Cho, Jong-Lyul Ghim, Sangmin Choe, Jin Ah Jung, Kyun-Seop Bae

    J Korean Soc Clin Pharmacol Ther | v.21, no.2, pp.95-103, Dec, 2013

    Abstract

    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.

    Keyword

    Amlodipine, Pharmacokinetics, Safety, Healthy volunteers