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

대한임상약리학회 (Korean Society for Clinical Pharmacology and Therapeutics)
권호 표지

올메살탄 메독시밀 제제의 생물학적 동등성과 용량 비례성에 관한 연구

Bioequivalence and Dose Proportionality of Olmesartan Medoxomil Formulations

  • 조성권 (연세대학교 의과대학 임상약리학과) ;
  • 김춘옥 (연세대학교 의과대학 임상약리학과) ;
  • 유수현 (연세대학교 의과대학 임상약리학과) ;
  • 오은실 (연세대학교 의과대학 임상약리학과) ;
  • 장성복 ((주)유한양행) ;
  • 박융식 ((주)유한양행) ;
  • 조경희 ((주)바이오코아) ;
  • 정재용 (연세대학교 의과대학 임상약리학과)
  • Cho, Sung Kweon (Department of Clinical Pharmacology Yonsei University College of medine) ;
  • Kim, Choon Ok (Department of Clinical Pharmacology Yonsei University College of medine) ;
  • Yu, Su Hyun (Department of Clinical Pharmacology Yonsei University College of medine) ;
  • Oh, Eun Sil (Department of Clinical Pharmacology Yonsei University College of medine) ;
  • Jang, Seong Bok (Yuhan Corporation) ;
  • Park, Yoong Sik (Yuhan Corporation) ;
  • Cho, Kyunghee (Biocore Corporation) ;
  • Chung, Jae-Yong (Department of Clinical Pharmacology Yonsei University College of medine)
  • 투고 : 2012.10.08
  • 심사 : 2012.12.17
  • 발행 : 2012.12.31
⟨ 이전 논문 다음 논문 ⟩

초록

Background: Olmesartan medoxomil is an angiotensin II receptor blocker commonly used in hypertension. First objective of this study was to evaluate the bioequivalence of two olmesartan formulations, Olmesartan 20 mg and 40 mg tablet (Yuhan, Pharmaceutical Corp. Seoul, Korea) as test drugs and $Olmetec^{(R)}$ 20 mg and 40 mg tablet (Daewoong, Pharmaceutical Corp. Seoul, Korea) as reference drugs. Second objective of this study was to evaluate the dose-proportionality of two formulations. Methods: Two studies (20 mg, 40 mg) were conducted as a randomized, open-label, 2-period, crossover design. Each subject received one 20 mg or 40 mg tablet of the reference or test formulation of olmesartan medoxomil in each study. Blood samples were obtained during the 48-hour period after the dose in each treatment period. Wash-out period was 1 week in each study. Concentrations of olmesartan medoxomil in plasma were analyzed using a liquid chromatography system with tandem mass-spectrometric detection (LC/MS/MS). The primary pharmacokinetic parameters were $C_{max}$ (maximum concentration) and $AUC_t$ (area under the concentration-time curve from time 0 to the last sampling time). Results: A total number of 40 healthy male volunteers participated in the study and 37 volunteers completed both treatment periods in 20 mg trial. All 40 participants completed both treatment periods in 40 mg trial. The 90 % CIs for the geometric mean ratios of the pharmacokinetic parameters (test:reference drug) were 0.93 ~ 1.04 for $AUC_t$ and 0.97 ~ 1.08 for $C_{max}$ in 20 mg trial. The 90 CIs were 0.94 ~ 1.02 for $AUC_t$ and 1.00 ~ 1.11 for $C_{max}$ in 40 mg trial. All parameters of two studies satisfy the range of bioequivalence criterion. Conclusion: The obtained results indicated that pharmacokinetic exposure to Olmesartan 20 mg and 40 mg tablet was bioequivalent to that of $Olmetec^{(R)}$ 20 mg and 40 mg tablet, respectively.

키워드

참고문헌

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