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Bioequivalence of cisapride-containing Cisaplus^{(R)} tablets (Daewoong Co.) to reference Prepulsid^{(R)} tablets (Janssen Co.) was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen healthy volunteers were divided randomly into two groups and administered orally at a cisapride dose of 10 mg in a 2times2 crossover design. There was a 1-week washout period between the treatments. Blood samples were taken at predetermined time intervals for 48 hr and the plasma cisapride concentrations were determined by an HPLC with UV detector. The area under the plasma drug concentration-time curve (AUC) was caltulated from time zero to the last sampling time by a linear trapezoidal method. The maximum observed plasma drug concentration (C_{max}) and the time to C_{max};(T_{max}) were estimated directly from the drug concentration-time data. Analysis of variance (ANOVA) showed that the apparent differences for AUC, C_{max};and;T_{max} were -7.52%,;-8.91%;and;-15.55%, respectively. The minimum detectable differences for AUC, C_{max};and;T_{max} between formulations were 14.52%,;11.57%;and;28.00% respectively, at alpha=0.05;and;1-beta=0.8;levels.;The;90% confidence intervals for AUC, C_{max};and;T_{max};were;-16.00sim0.97%,;-15.67sim-2.15%;and;-31.88%sim0.84%, respectively. These results satisfy the bioequivalence criteria of KFDA guidelines, indicating that the two formulations of cisapride are bioequivalent.
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