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