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KMID : 0369819920220030229
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Jorunal of Korean Pharmaceutical Sciences
1992 Volume.22 No. 3 p.229 ~ p.235
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Bioequivalence Evaluation of Commercially Available Choline Magnesium Trisalicylate Tablets in Healthy Volunteers
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박경호/Park KH
신현택/이민화/고영율/Shin HT/Lee MH/Goh YY
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Abstract
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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® tablet (Hyundai Pharm. Ind. Co., Ltd., Korea) and reference product was Trilisate® tablet (Purdue Frederick, U.S.A.). Both products contained 500 mg salicylate. In the study, ten volunteers were administered one tablet of Trimax® or Trilisate® 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® and Trimax® were 388.88±74.99μg?hr/ml and 390.63±63.02μg?hr/ml hrlm!, respectively, which were not significantly different (p>0.05). The mean peak concentrations (Cmax) and mean times to peak (Tmax) of Trilisate® and Trimax® were 71.1±12.2 and 72.9±10.7μg/ml, and 72±33 and 57±36min, respectively, which were not significantly different (p>0.05). The mean terminal phase half-lives (tl/2ter) of the two products were 2.57±0.47 and 2.43±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® tablet was not significantly different from that of Trilisate® tablet.
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KEYWORD
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Bioavailability, Bioequivalence, Choline magnesium trisalicylate, Volunteers, Absorption, Pharmacokinetics
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