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오메프라졸 장용성제제에 대한 생물학적 동등성 평가
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저자명
김종국,정은주,이은진,신희종,이원근,Kim. Chong-Kook,Jeong. Eun-Ju,Lee. Eun-Jin,Shin. Hee-Jong,Lee. Won-Keun
간행물명
藥劑學會誌
권/호정보
1993년|23권 1호|pp.41-49 (9 pages)
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한국약제학회
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정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

The bioequivalence of two omeprazole enteric-coated products was evaluated in 16 normal male volunteers (age 26-32 yr, body weight 57-75 kg) following single oral administration. Test product was enteric-coated KD-182 tablet (Chong Kun Dang Corp., Korea) and reference product was $Rosec^{circledR}$ capsule containing enteric-coated pellets of omeprazole (Yuhan Corp., Korea). Both products contain 20 mg of omeprazole. One tablet or capsule of the test or the reference product was administered to the volunteers, respectively, by randomized two period cross-over study ($2;{ imes};2$ Latin square method). Average drug concetrations at each sampling time and pharmacokinetic parameters calculated were not significantly different between two products(p>0.05); the area under the concentrationtime curve to last sampling time (8 hr) $(AUC_{0-8hr})$ $(1946.5{pm}675.3;vs;2018.3{pm}761.6;ng{cdot}hr/ml)$, AUC from time zero to infinite $(AUC_{o-infty})$ $(2288.6{pm}1212.8;vs;2264.9{pm}1001.3;ng{cdot}hr/ml)$, maximum plasma concentration $(C_{max})$ $(772.5{pm}283.3;vs;925.8{pm}187.7;ng/ml)$, time to maximum plasma concentration $(T_{max})$ $(2.38{pm}1.06;vs;2.34{pm}1.09;hr)$, apparent elimination rate constant $(k_{ell})$ $(0.5339{pm}0.2687;vs;0.5769 {pm}0.2184;hr^{-I})$, apparent absorption rate constant $(k_a)$ $(1.1536{pm}0.5278;vs;0.9739{pm}0.9507 hr^{-1})$ and mean residence time (MRT) $(3.13{pm}0.73;vs ;3.41{pm}1.04;hr)$. The differences of mean $(AUC_{0-8hr})$, $C_{max}$, $T_{max}$ and MRT between the two products (3.69, 19.83, 1.32 and 8.99%, respectively) were less than 20%. The power $(1-{eta})$ and treatment difference $( riangle)$ for $AUC_{o-8hr}$ $C_{max}$ and MRT were more than 0.8 and less than 0.2, respectively. Although the power for $T_{max}$ was under 0.8, $T_{max}$ of the two products was not significantly different each other(p>0.05). These results suggest that the bioavailability of KD-182 tablet is not significantly different from that of $Rosec^{circledR}$ capsule. Therefore, two products are bioequivalent based on the current results.