Journal of Korean Society for Clinical Pharmacology and Therapeutics (임상약리학회지)

Korean Society for Clinical Pharmacology and Therapeutics (대한임상약리학회)
권호 표지

Evaluation of Safety, Tolerability and Pharmacokinetics of Lebecel (DDB-S) ; a Phase I Clinical Trial

건강 자원자에서 레베셀$^{\circledR}$주(DDB-S)의 안정성, 약동학적 특성평가를 위한 제 1상 임상시험

  • Chung, Jae-Yong (Department of Pharmacology, Seoul National University College of Medicine, Clinical Pharmacology Unit and Clinical Trial Center, Seoul National University Hospital) ;
  • Lim, Hyeong-Seok (Department of Pharmacology, Seoul National University College of Medicine, Clinical Pharmacology Unit and Clinical Trial Center, Seoul National University Hospital) ;
  • Bae, Kyun-Seop (Department of Pharmacology, Seoul National University College of Medicine, Clinical Pharmacology Unit and Clinical Trial Center, Seoul National University Hospital) ;
  • Yu, Kyung-Sang (Department of Pharmacology, Seoul National University College of Medicine, Clinical Pharmacology Unit and Clinical Trial Center, Seoul National University Hospital) ;
  • Hong, Kyoung-Sup (Department of Pharmacology, Seoul National University College of Medicine, Clinical Pharmacology Unit and Clinical Trial Center, Seoul National University Hospital) ;
  • Cho, Joo-Youn (Department of Pharmacology, Seoul National University College of Medicine, Clinical Pharmacology Unit and Clinical Trial Center, Seoul National University Hospital) ;
  • Yi, So-Young (Department of Pharmacology, Seoul National University College of Medicine, Clinical Pharmacology Unit and Clinical Trial Center, Seoul National University Hospital) ;
  • Moon, Jun-Ok (Department of Pharmacy, Pusan University) ;
  • Lee, Chi-Oh (Department of Pharmacy, Pusan University) ;
  • Jang, In-Jin (Department of Pharmacology, Seoul National University College of Medicine, Clinical Pharmacology Unit and Clinical Trial Center, Seoul National University Hospital) ;
  • Shin, Sang-Goo (Department of Pharmacology, Seoul National University College of Medicine, Clinical Pharmacology Unit and Clinical Trial Center, Seoul National University Hospital)
  • 정재용 (서울대학교 의과대학 약리학교실,서울대학교병원 임상약리실,서울대학교병원 임상의학연구소 임상시험센터) ;
  • 임형석 (서울대학교 의과대학 약리학교실,서울대학교병원 임상약리실,서울대학교병원 임상의학연구소 임상시험센터) ;
  • 배균섭 (서울대학교 의과대학 약리학교실,서울대학교병원 임상약리실,서울대학교병원 임상의학연구소 임상시험센터) ;
  • 유경상 (서울대학교 의과대학 약리학교실,서울대학교병원 임상약리실,서울대학교병원 임상의학연구소 임상시험센터) ;
  • 홍경섭 (서울대학교 의과대학 약리학교실,서울대학교병원 임상약리실,서울대학교병원 임상의학연구소 임상시험센터) ;
  • 조주연 (서울대학교 의과대학 약리학교실,서울대학교병원 임상약리실,서울대학교병원 임상의학연구소 임상시험센터) ;
  • 이소영 (서울대학교 의과대학 약리학교실,서울대학교병원 임상약리실,서울대학교병원 임상의학연구소 임상시험센터) ;
  • 문전옥 (부산대학교약학대학) ;
  • 이치오 (부산대학교약학대학) ;
  • 장인진 (서울대학교 의과대학 약리학교실,서울대학교병원 임상약리실,서울대학교병원 임상의학연구소 임상시험센터) ;
  • 신상구 (서울대학교 의과대학 약리학교실,서울대학교병원 임상약리실,서울대학교병원 임상의학연구소 임상시험센터)
  • Published : 2001.12.30

⟨ Previous Next ⟩

Abstract

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.

Keywords