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박경미(Kyung Mi Park),이미경(Mi Kyung Lee),임수정(Soo Jeong Lim),김종국(Chong Kook Kim),박정숙(Jeong Sook Park),김진기(Jin Ki Kim),최성희(Sung Hi Choi),민경아(Kyung Ah Min) 한국응용약물학회 2001 Biomolecules & Therapeutics(구 응용약물학회지) Vol.9 No.4
N/A The bioequivalence of two triflusal products was evaluated with 20 healthy volunteers following single oral dose according to the guidelines of Korea Food and Drug Administration (KFDA). Trisal^? capsule (Whanin Pharm. Corp., Korea) and Disgren^? capsule (Myung-In Pharm. Corp., Korea) were used as test product and reference product, respectively. Both products contain 300㎎ of trifusal. One capsule of test product or reference product was orally administered to the volunteers, respectively, by randomized two period crossover study (2×2 Latin square method). Blood samples were taken at predetermined time intervals for 4 hours and the determination of trifusal was accomplished using semi-microbore HPLC equipped with automated column switching system. The analytical method with HPLC was validated according to the Bioanalytic Method Validation guideline by FDA prior to determining the plasma samples. The pharmacokinetic parameters (AUC_(0-4h), C_max, and T_max) were calculated and ANOVA test was utilized for statistical analysis of parameters. As a result of the assay validation, the limit of quantification of trifusal in human plasma by current assay procedure was 50 ng/ml using 500 ㎕ of plasma. The accuracy of the assay was from 97.76% to 116.51% while the intra-day and inter-day coefficient of variation of the same concentration range was less than 15%. Average drug concentration at the designated time intervals and pharmacokinetic parameters calculated were not significantly different between two products (p>0.05). The difference of mean AUC_(0→4hr), C_max, and T_max between the two products (2.92, 4.39, and -2.44%, respectively) were less than 20%. The power (1-β) and treatment difference (Δ) for AUC_(0→4hr) and C_max were more than 0.8 and less than 0.2, respectively. Although the power for T_max was under 0.8, T_max, of the two products was not significantly different from each other (p>0.05). These results satisfied the criteria of KFDA guideline for bioequivalence, indicating the two products of triflusal were bioequivalent.