신성대학교
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 Atenolol Tablet Preparations in Korean Healthy Male Volunteers
[STEP1]서지반출 형식 선택
파일형식
@
서지도구
SNS
기타
[STEP2]서지반출 정보 선택
  • 제목
  • URL
돌아가기
확인
취소
  • Bioequivalence Evaluation of Two Atenolol Tablet Preparations in Korean Healthy Male Volunteers
  • Bioequivalence Evaluation of Two Atenolol Tablet Preparations in Korean Healthy Male Volunteers
저자명
Gwak. Hye-Sun,Chun. In-Koo
간행물명
The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology
권/호정보
2007년|15권 3호|pp.187-191 (5 pages)
발행정보
한국응용약물학회
파일정보
정기간행물|ENG|
PDF텍스트
주제분야
기타
이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

This study was conducted to compare the bioavailability of two brands of atenolol (50 mg) tablets, which are a generic product of $Ditent^{circledR}$ (Daewon Pharmaceutical Co., Ltd., Korea) and an innovator product $Tenormin^{circledR}$ (Hyundai Pharm. Ind. Co., Ltd., Korea), in 20 healthy Korean male volunteers. The volunteers received a single 50 mg dose of each atenolol formulation according to a randomized, two-way cross-over design. The washout period between treatments was 1 week. Plasma samples were obtained over a 24-hour interval, and atenolol concentrations were determined by HPLC with a fluorescence detector. From the plasma atenolol concentration vs. time curves, the following parameters were compared: area under the plasma concentration-time curve ($AUC_{0-24}$), peak plasma concentration ($C_{max}$), time to reach peak plasma concentration ($T_{max}$), and terminal first order elimination half-life ($t_{1/2}$). No statistically significant difference was obtained between the $T_{max}$ values, and the logarithmic transformed $AUC_{0-24}$ and $C_{max}$ values of the two products. The 90% confidence interval for the ratio of the logarithmically transformed AUC and $C_{max}$ values of $Ditent^{circledR}$ over those of $Tenormin^{circledR}$ were calculated to be between 0.85 and 1.04, and 0.89 and 1.07, respectively; both were within the bioequivalence limit of 0.80-1.25. The mean of $T_{max}$ in $Tenormin^{circledR}$ group was 3.1 hour, and that in Ditent$^{circledR}$ group was 3.2 hour. The values of $t_{1/2}$ between the two products were found comparable, and the mean values were 5.2 hour in the both products. Based on these results, it was concluded that $Ditent^{circledR}$ was comparable to $Tenormin^{circledR}$ in both the rate and extent of absorption, indicating that $Ditent^{circledR}$ was bioequivalent to the reference product, $Tenormin^{circledR}$.