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

Korean Society for Clinical Pharmacology and Therapeutics (대한임상약리학회)
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Bioequivalence of Cyclosporine Microemulsion Preparation NEOPLANTA in Normal Adult Volunteers

정상 성인에서 Cyclosporine 연질 경구제제 네오프란타의 생물학적 동등성에 관한 연구

  • Yu, Nae-Choon (Department of Clinical Pharmacology Yonsei University College of Medicine and Severance Hospital) ;
  • Na, Dae-Ro (Department of Pharmacology Yonsei University College of Medicine and Severance Hospital) ;
  • Park, Min-Soo (Department of Clinical Pharmacology Yonsei University College of Medicine and Severance Hospital) ;
  • Kim, Kyung-Hwan (Department of Pharmacology and Department of Clinical Pharmacology Yonsei University College of Medicine and Severance Hospital)
  • 유내춘 (연세대학교 세브란스병원 임상약리학과) ;
  • 나대로 (연세대학교 의과대학 약리학교실) ;
  • 박민수 (연세대학교 세브란스병원 임상약리학과) ;
  • 김경환 (연세대학교 의과대학 약리학교실, 세브란스병원 임상약리학과)
  • Published : 1996.12.30

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Abstract

Background: To test the bioequivalence, the bioavailability of the newly marketed cyclosporine microemulsion preparation NEOPLANTA(Hanmi Pharm. Co., Ltd, Seoul, Korea) was compared with SANDIMMUNE NEORAL(Sandoz Pharm. Co., Basel, Swiss) as a reference drug. Method: Twenty four normal volunteers were entered to the study(Yonsei University College of Medicine, Severance Hospital IRB approval No.9606). They were administered 175mg of cyclosporine in $2\;{\times}\;2$ crossover design with two weeks of drug free period between doses. The blood sampling was done before and after administration upto 24hours. The concentration of cyclosporine was measured by radioimmunoassay. A non-compartmental method was applied for analysis of the concentration-time data. Results: The area under the curve(AUC), maximal concentration of drug(Cmax) and time to reach Cmax(Tmax) did not show any significant difference between two preparations by ANOVA. The mean differences of AUC, Cmax and Tmax were within 20% of the reference drug, those were 8.31%, 2.58% and -4.73%, respectively. The confidence limits of three parameters were satisfied the bioequivalence criteria. Conclusion: These results suggest that the test cyclosporine microemulsion preparation NEOPLANTA is bioequivalent to the reference drug.

배경 : 최근 국내에서 시판되는 cyclospo-rine연질 경구제제인 네오프란타(한미약품)의 생체이용율을 비교검토하기 위하여 대조약인 산디문 뉴오랄(한국 산도스사)과 생물학적 동등성시험을 실시하였다. 방법 : 20-40세되는 건강한 지원자 24명을 대상으로 라틴방격법으로 2회에 걸쳐 cyclosporine 175mg을 무작위 교차투여하였다. 약물투여전 및 투여후 24시간까지 총 13회 채혈하여 전혈내 cyclosporine농도를 방사면역법으로 측정하였다. 결과 : 생체이용율의 지표로 대조약 산디문뉴오랄과 시험약 네오프란타의 곡선하농도(AUC), 최고혈중농도(Cmax) 및 최고혈중농도 도달시간(Tmax)을 분산분석한 바 대조약과 시험약사이에 유의한 차이가 없었으며 각각의 평균치 차이는 8.31%, 2.58% 및 -4.73%로서 20%이내이었다. 또한 시험약의 AUC, Cmax 및 Tmax의 신뢰한계는 동등성 기준을 만족시켰다. 결론 : 이상의 결과로 보아 시험약 네오프란타는 기준약 산디문뉴오랄과 비교하여 생물학적으로 동등하다고 인정된다.

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