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KMID : 0043319900130020180
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Archives of Pharmacal Research
1990 Volume.13 No. 2 p.180 ~ p.186
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Bioequivalence Study of Ranitidine Tablet
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Shim CK
Hong JS/Lee CK/Han IS/Choi KS
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Abstract
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A bioequivalence study of ranitidine tablets was conducted according to the Korean Guidline for the Bioequivalence Test using twelve healthy male subjects. The plasma concentration-time curves of ranitidine from the test and reference tablets showed profound multiple peak phenomenon in each subject as reported earlier. However, the area under the plasma concentration-time curve (AUC) and the maximum plasma concentration at the first peak (Cmax1) of the two preparations was proven to be equal when analyzed satistically according to the criteria of the guidline; i.e., statistical power (1-beta) was calculated to be over O.8 under the condition of alpha=5% and delta(minimum detectable difference)=20%, and the confidence interval of the difference in AUC at 95% confidence level was in the range of +/- 20%, which statisfied the criteria of bioequivalence. Equivalence of the peak concentration of ranitidine at the second peak (Cmax2), and the time to reach the first (Tmax1) and second (Tmax2) peaks were not statistically guaranteed in this study. More subjects were needed to verify the bioequivalence of Cmax2, Tmax1 and Tmax2 between the two tablets. However, we conclude that the test and reference tablets are bioequivalent taking the therapeutic characteristics of the ranitidine preparations into consideration.
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KEYWORD
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