- 비페닐디메칠디카르복실레이트 제제의 생물학적 동등성 시험
- ㆍ 저자명
- 한상수,함성호,손동환,김재백,Han. Sang-Soo,Ham. Seong-Ho,Sohn. Dong-Hwan,Kim. Jae-Baek
- ㆍ 간행물명
- 藥劑學會誌
- ㆍ 권/호정보
- 1994년|24권 2호|pp.67-72 (6 pages)
- ㆍ 발행정보
- 한국약제학회
- ㆍ 파일정보
- 정기간행물| PDF텍스트
- ㆍ 주제분야
- 기타
Bioequivalence (BE) test of biphenyl dimethyl dicarboxylate (DDB) tablets was performed. Normal healthy male volunteers (n = 20) were randomly divided into 2 groups, and reference $(Nissel{circledR})$ and test $(Livital{circledR})$ tablets of DDB $(25mg{ imes}8;Tab.;= ;200;mg)$ were given orally by balanced two-period cross-over design. The serum concentration was determined by high performance liquid chromatography. The pharmacokinetic parameters, AUC, $C_{max}$, and $T_{max}$ obtained after drug administration were statistically analyzed. Statistical evaluation of the data involved an analysis of variance (ANOVA) for cross-over design. The results were within 20% differences of mean value in AUC, $C_{max}$, and $T_{max}$ between reference and test tablets. The results of ANOVA showed no significant differences for "between group or subject" and "period". The test tablet was bioequivalent with the reference tablet in the AUC, $C_{max}$, and $T_{max}$.