건강한 지원자를 대상으로 한 시판 Choline Magnesium Trisalicylate 정제의 생물학적 동등성 평가

Bioequivalence Evaluation of Commercially Available Choline Magnesium Trisalicylate Tablets in Healthy Volunteers

The bioequivalence of two commercial choline magnesium trisalicylate (CMT) tablets was evaluated in 10 normal male subjects (age 21-27 yr, mean 23 yr) following single oral administrations of two products. Test product was $Trimax^{\circledR}$ tablet (Hyundai Pharm. Ind. Co., Ltd., Korea) and reference product was $Trilisate^{\circledR}$ tablet (Purdue Frederick, U.S.A.). Both products contained 500 mg salicylate. In the study, ten volunteers were administered one tablet of $Trimax^{\circledR}$ or $Trilisate^{\circledR}$ with randomized two period cross-over study. The pharmacokinetic parameters of two products were statistically compared using Student's t-test and ANOVA. When Student's t-test was applied, mean area under the curves (AUC) of $Trilisate^{\circledR}$ and $Trimax^{\circledR}$ were $388.88{\pm}74.99\; {\mu}g{\cdot}hr/ml$ and $390.63{\pm}63.02\;{\mu}g{\cdot}hr/ml$ hrlm!, respectively, which were not significantly different (p>0.05). The mean peak concentrations $(C_{max})$ and mean times to peak $(T_{max})$ of $Trilisate^{\circledR}$ and $Trimax^{\circledR}$ were $71.1{\pm}12.2$ and $72.9{\pm}10.7\;{\mu}g/ml$, and $72{\pm}33$ and $57{\pm}36min$, respectively, which were not significantly different (p>0.05). The mean terminal phase half-lives $(t_{l/2ter})$ of the two products were $2.57{\pm}0.47$ and $2.43{\pm}0.40$ hr, and also they were not significantly different (p>0.05). When ANOVA was applied, the parameters of the two products were not also significantly different each other. Based on the above results, it has been concluded that the bioavailability of $Trimax^{\circledR}$ tablet was not significantly different from that of $Trilisate^{\circledR}$ tablet.