Journal of Korean Society for Clinical Pharmacology and Therapeutics (임상약리학회지)

Korean Society for Clinical Pharmacology and Therapeutics (대한임상약리학회)
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Comparison of Pharmacokinetic Characteristics and Safety Between JW Amlodipine$^{(R)}$ Tablet 5 mg and Novarsc$^{(R)}$ Tablet 5 mg in Healthy Male Volunteers

건강한 성인 남성에서 중외 암로디핀$^{(R)}$ 캡슐 5 mg과 노바스크$^{(R)}$정 5 mg의 약동학 특성 및 안전성 비교

  • Kim, Yo Han (Department of Clinical Pharmacology and Therapeutics, Asan Medical Center) ;
  • Lim, Hyeong-Seok (Department of Clinical Pharmacology and Therapeutics, Asan Medical Center) ;
  • Cho, Sang-Heon (Department of Clinical Pharmacology, Inha University Hospital, Inha University Scull of Medicine) ;
  • Ghim, Jong-Lyul (Department of Clinical Pharmacology, Busan Paik Hospital, Inha University Scull of Medicine) ;
  • Choe, Sangmin (Clinical Trials Center, Pusan National University Hospital) ;
  • Jung, Jin Ah (Clinical Trial Center, Samsung Medical Center) ;
  • Bae, Kyun-Seop (Department of Clinical Pharmacology and Therapeutics, Asan Medical Center)
  • 김요한 (서울아산병원 임상약리학과) ;
  • 임형석 (서울아산병원 임상약리학과) ;
  • 조상헌 (인하대학교 의과대학 부속병원 임상약리학과 및 인하대학교 의과대학) ;
  • 김종률 (인제대학교 부산백병원 임상약리학과) ;
  • 최상민 (부산대학교병원 임상시험센터) ;
  • 정진아 (삼성서울병원 임상시험센터) ;
  • 배균섭 (서울아산병원 임상약리학과)
  • Received : 2013.07.31
  • Accepted : 2013.10.10
  • Published : 2013.12.31
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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 $C_{max}$ and $AUC_{last}$ 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.

Keywords

References

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