KMID : 0043319950180060385
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Archives of Pharmacal Research 1995 Volume.18 No. 6 p.385 ~ p.390
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Pharmacokinetics of Two Cyclosporine Formulations Using FPIA and HPLC Assay in Volunterrs
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Kwon Kwang-II
Park Jong-Woo Lee Chang-Hyun Kim Moo-Heon
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Abstract
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The analytical methods for the analysis of cyclosporine (CsA), a fluorescence polarization immunoassay (FPIA) and HPLC method, were compared in a pharmacokinetic study of two CsA soft capsule formultaions (; Sandoz, ; Hanmi). Sixteen healthy volunteers completed the study and each subjected single doses ( mg) of the test and the reference formulations in a two-way crossover design with a one-week drug-free interval between doses. Following each administration, whole blood concentrations of CsA were monitored over a period of 24 hour by both FPIA and HPLC methods. Blood concentrations nad pharmacokinetic parameters determined by either analytical method showed large intersubject variation, with the FPIA data showing relatively higher magnitude of intersubjecte variation than the HPLC data. The blood concentrations determined by FPIA were 1.1-1.3 times higher than those determined by HPLC. There were strong and significant correlations between the two methods (r>0.83 : p<0.0001). Intersubuject variation for the of the test formulation was slightly reduced without statistical significance (paried -t test : p>0.05 was earlier nad was slightly lower for the test formulation, and MRT determined separately from the data obtained by the two methods for the two formulations were examined by analyses of variance (ANOVA) for the bioequivalency evaluation. Results of ANOVA and confidence limits of terst/reference ratios of , , and MRT, and statistical tests indicated the bioequivalence of the two formulations (i.e., test/reference ratio was within ) except for and . The mean of tmax also showed 11.1% and 9.3% differences but the detection limit were 29.2% and 29.6% as determined by FPIA and HPLC resepctively. This experiments suggest that the data yielded for the two formulations demonstrated that they were bioequivalent.
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KEYWORD
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Cyclosporine, Pharmacokinetics, Bioequivalence, FPIA, HPLC
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