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서지반출
건강 자원자에서 레베셀$^{circledR}$주(DDB-S)의 안정성, 약동학적 특성평가를 위한 제 1상 임상시험
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  • 건강 자원자에서 레베셀$^{circledR}$주(DDB-S)의 안정성, 약동학적 특성평가를 위한 제 1상 임상시험
저자명
정재용,임형석,배균섭,유경상,홍경섭,조주연,이소영,문전옥,이치오,장인진,신상구,Chung. Jae-Yong,Lim. Hyeong-Seok,Bae. Kyun-Seop,Yu. Kyung-Sang,Hong. Kyoung-Sup,Cho.
간행물명
臨床藥理學會誌= The journal of Korean Society for Clinical Pharmacology and Therapeutics
권/호정보
2001년|9권 2호|pp.188-196 (9 pages)
발행정보
대한임상약리학회
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기타
이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

Background : Low solubility and poor oral absorption have been major problems of DDB(Dimethyl Dime-thoxy Biphenylate), the liver protection agent. The purpose of the study was to evaluate safety, tolerablilty, and pharmacokinetics of DDB-S(Dimethoxybiphenylmonocarboxylate hydro-chloride) which was the newly developed soluble injectable form of DDB. Method : Single dose trial was conducted in 24 healthy Korean subjects with single blind, randomized, placebo controlled parallel-group design( 4 groups : 7.5, 15, 30, 60mg). DDB-S was administrated by intravenous infusion during 60 minutes. Serial blood and urine sample were collected till 24 hours after the drug administration. Plasma concentrations were assayed by HPLC. Pharmacokinetic parameters were analyzed by noncompartmental methods. Results : Total 13 cases of adverse events from 7 subjects were reported. All the events were mild, temporary, and spontaneously resolved. There were no differences in dose normalized AUC, dose normalized Cmax, CL, Vd, Tmax, Fe, $CL_R$ and elimination rate constant between groups. Linear regression analysis confirmed PK linearity within this dose range. Half of the dose$(49.86{pm}10.97%)$ was excreted as an unchanged form through kidney. Conclusion : DDB-S was safe in Korean healthy subjects. It showed linear pharmacokinetic characteristics. Phase II clinical study for patients will be conducted.