기관회원 [로그인]
소속기관에서 받은 아이디, 비밀번호를 입력해 주세요.
개인회원 [로그인]

비회원 구매시 입력하신 핸드폰번호를 입력해 주세요.
본인 인증 후 구매내역을 확인하실 수 있습니다.

회원가입
서지반출
트리테이스프로텍트 ?정(라미프릴 10mg)에 대한 라미프린 ?정의 생물학적동등성
[STEP1]서지반출 형식 선택
파일형식
@
서지도구
SNS
기타
[STEP2]서지반출 정보 선택
  • 제목
  • URL
돌아가기
확인
취소
  • 트리테이스프로텍트 ?정(라미프릴 10mg)에 대한 라미프린 ?정의 생물학적동등성
저자명
오수연,조종태,김형건,김윤균,Oh. Soo-Yeon,Cho. Jong-Tae,Kim. Hyung-Gun,Kim. Yoon-Gyoon
간행물명
藥劑學會誌
권/호정보
2008년|38권 1호|pp.73-78 (6 pages)
발행정보
한국약제학회
파일정보
정기간행물|
PDF텍스트
주제분야
기타
이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

To evaluate the bioequivalence of two ramipril formulations, a standard 2-way randomized cross-over study was conducted in twenty-six healthy male Korean volunteers. A single oral dose of 10 mg of test formulation $Ramiprin^{(R)}$ (tablet) or reference formulation Tritace $Protect^{(R)}$ (tablet) was administered with one-week washout period. Plasma concentrations of ramipril were assayed over a period of 12 hr with a well validated method using liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS). The values of area under the plasma concentration-time curve, from time zero to last sampling time $(AUC_t)$ and from time zero to time infinity $(AUC_{inf})$ were $77.45{pm}44.78;and;78.96{pm}45.64$ for test, and $70.30{pm}42.27;and;71.99{pm}43.55ng;hr/mL$ for reference formulation, respectively. Similarly, maximum concentration $(C_{max})$ and elimination half-life $(t_{1/2})$ were $65.61{pm}19.96ng/mL$ and $2.15{pm}0.75hr$ for test, and $63.63{pm}25.50ng/mL$ and $2.16{pm}0.73hr$ for reference formulations, respectively. Time to reach maximum concentration $(T_{max})$ for the test and the reference, were $0.51{pm}0.22hr;and;0.52{pm}0.18hr$, respectively. The parametric 90% confidence intervals on the mean of the differences between the two formulations (test-reference) of the log-transformed values of $AUC_t;and;C_{max}$ were 1.03 to 1.19 and 0.98 to 1.17, respectively. The overall results indicate that the two formulations are bioequivalent and can be prescribed interchangeably.