J Korean Soc Clin Pharmacol Ther.  2013 Dec;21(2):95-103. 10.12793/jkscpt.2013.21.2.95.

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

• Kim YH
• Lim HS
• Cho SH
• Ghim JL
• Choe S
• Jung JA
• Bae KS

• KMID: 2203222
• DOI: http://doi.org/10.12793/jkscpt.2013.21.2.95

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

MeSH Terms

Amlodipine
Calcium Channels
Cross-Over Studies
Electrocardiography
Healthy Volunteers
Humans
Hypertension
Male*
Mass Spectrometry
Pharmacokinetics
Physical Examination
Plasma
Vital Signs
Amlodipine
Calcium Channels

Figure

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  Figure 1. Plasma concentration (mean and standard deviation) time curves of amlodipine after a single oral administration of the reference and test formulations.

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  Figure 2. Individual profiles of amlodipine after a single oral administration of the test and reference formulations.

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  Figure 3. Mean (SD) Systolic (upper) and diastolic blood pressure (lower) after a single oral administration of the test and reference amlodipine 5 mg formulations.

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