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

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

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.