건강한 지원자에 있어서 염산테르비나핀 함유 라미실정과 무조날정의 약물동력학적 비교

Pharmacokinetic Comparison of Lamisil Tablet and Muzonal Tablet Containing Terbinafine HCl in Healthy Volunteers

  • 최한곤 (영남대학교 약학대학/약품개발연구소) ;
  • 용철순 (영남대학교 약학대학/약품개발연구소) ;
  • 이종달 (영남대학교 약학대학/약품개발연구소) ;
  • 우종수 (한미약품 중앙연구소) ;
  • 이경희 (영남대학교 의과대학) ;
  • 유봉규 (영남대학교 약학대학/약품개발연구소)
  • Choi Han-Gon (College of Pharmacy/Institute of Drug Research, Yeungnam University) ;
  • Yong Chul Soon (College of Pharmacy/Institute of Drug Research, Yeungnam University) ;
  • Rhee Jong-Dhal (College of Pharmacy/Institute of Drug Research, Yeungnam University) ;
  • Woo Jong-Soo (Central R&D Center, Hanmi Corp) ;
  • Lee Kyung Hee (College of Medicine, Yeungnam University) ;
  • Yoo Bong Kyu (College of Pharmacy/Institute of Drug Research, Yeungnam University)
  • 발행 : 2005.08.01

초록

Financial standing of National Health Insurance has been experiencing a grave deterioration during the last 4-5 years, and the yearly amount paid by the insurance for drug expense rose up to 4 trillion won recently. Furthermore, the ratio of drug expenses in the total expenditure of the insurance reached about $25\%$, showing the tendency to be levelled off. As a measure to improve the financial deterioration of the insurance and to encourage generic substitution among the health professionals, we compared pharmacokinetic parameters of brand name drug (Lamisil) and generic drug (Muzonal) containing terbinafine HCl in healthy volunteers. The area under the curve (AUC) of the two drugs showed $2220.4\pm784.7\;and\;2143.1\pm861.6hr{\cdot}ng/ml$ in the corresponding order and no statistically significant difference was identified. The peak concentration $(C_{max})$ of the generic drug demonstrated $566.6\pm246.2 ng/ml$ compared to $550.8\pm204.0$ of brand name drug, which was not significantly different either. Time to reach peak concentration showed about 6 minutes difference between the drugs, which has no clinical significance to the treatment of dermatomycosis and dermatophytosis.

키워드

참고문헌

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