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
Bioequivalence Evaluation of Two brands of Cetirizine HCl 10 mg Tablets (Zyrix and Zyrtec) in Healthy Male Volunteers
[STEP1]서지반출 형식 선택
파일형식
@
서지도구
SNS
기타
[STEP2]서지반출 정보 선택
  • 제목
  • URL
돌아가기
확인
취소
  • Bioequivalence Evaluation of Two brands of Cetirizine HCl 10 mg Tablets (Zyrix and Zyrtec) in Healthy Male Volunteers
  • Bioequivalence Evaluation of Two brands of Cetirizine HCl 10 mg Tablets (Zyrix and Zyrtec) in Healthy Male Volunteers
저자명
Im. Ho-Taek,Won. Jong-Hoen,Cho. Sung-Hee,Lee. Heon-Woo,Park. Wan-Su,Rew. Jae-Hwan,Lee. Kyung-Tae
간행물명
藥劑學會誌
권/호정보
2005년|35권 5호|pp.355-360 (6 pages)
발행정보
한국약제학회
파일정보
정기간행물|ENG|
PDF텍스트
주제분야
기타
이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

The purpose of the present study was to evaluate the bioequivalence of two cetirizine HCl tablets, Zyrtec tablet (UCB Pharm. Co., Ltd. Korea, reference product) and Zyrix tablet (Kukje Pharm. Co., Ltd., Korea, test product), according to the guidelines of Korea Food and Drug Administration (KFDA). After adding an internal standard (diazepam), plasma samples were extracted using 1 mL of dichloromethane. Compounds extracted were analyzed by reverse-phase HPLC with ultra-violet detector. This method for determination cetirizine is proved accurate and reproducible with a limit of quantitation of 10 ng/mL in male plasma. Twenty-four healthy male Korean volunteers received each medicine at the cetirizine HCl dose of 10 mg in a $2{ imes}2$ crossover study. There was a one-week wash out period between the doses. Plasma concentrations of cetirizine were monitored for over a period of 24 hr after the administration. AUC (the area under the plasma concentration-time curve) was calculated by the linear trapezoidal rule. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUC and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals for the log transformed data were acceptable range of log 0.8 to log 1.25 $(e.g.,;log;0.93-log;1.08;for;AUC_{0-t},;log;0.91-log;1.08;for;AUC_{0-{infty}};and;log;1.01-log;1.11;for;C_{max})$. The major parameters, AUC and $C_{max}$ met the criteria of KFDA for bioequivalence indicating that Zyrix tablet is bioequivalent to Zyrtec tablet.