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

Affiliations
  • 1Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, Seoul, Korea. ksbae@amc.seoul.kr
  • 2Department of Clinical Pharmacology and Therapeutics, University of Ulsan College of Medicine, Korea.
  • 3Department of Clinical Pharmacology, Inha University Hospital, Inha University Scull Of Medicine, Incheon, Korea.
  • 4Department of Clinical Pharmacology, Busan Paik Hospital, Busan, Korea.
  • 5Clinical Trials Center, Pusan National University Hospital, Busan, Korea.
  • 6Clinical Trial Center, Samsung Medical Center, Seoul, Korea.

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
Full Text Links
  • JKSCPT
Actions
Cited
CITED
export Copy
Close
Share
  • Twitter
  • Facebook
Similar articles
    DB Error: unknown error