건강한 지원자에 있어서 염산테르비나핀 함유, 라미실정과 무조날정의 약물동력학적 비교

Abstract

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 ± 784.7 and 2143.1±861.6hr.mg/㎖ in the corresponding order and no statistically significant difference was identified. The peak concentration (Cmax) of the generic drug demonstrated 566.6±246.2 ng/㎖ compared to 550.8±204.0 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.