Abstract��
OBJECTIVE To observe the bioavailability of domestic cisapride capsule and Prepuside. METHODS A single oral dose of 15 mg domestic Cisapride capsule or Prepuside was given to 12 healthy volunteers in a randomized crossover study.Cisapride concentrations in plasma were determined by HPLC method. RESULTS The results showed that the plasma concentration-time curves of the two products were all fitted to two-compartment model.:-t-peak of domestic Cisapride capsule and Prepuside were (1.58��0.31) and (1.65����0.36) h��AUC were (822.98��80.60) and (802.39��18.59) ��g��h��L-1,cmax(65.52��5.15) and (64.29��5.42) ��g��L-1��respectively.AUC0��tof two products were (817.35��80.67) and (801.94��73.33) ��g��h��L-1��Actual mesured cmax(70.74��6.03)and (70.61��6.93) ��g��L-1��Actual measured tmax(1.8��0.3) and (1.6��0.2) h��respectively.The relative bioavailability of domestic to imported tablets was (102.0��4.9)%. CONCLUSION There were no statistically significant difference between the two products (P��0.05).The results demonstraed that the two preparations were bioequivalent.