Assessment of the bioavailability and bioequivalence of paracetamol suppository

Objective:To compare the relative bioavailability and bioequivalence of paracetamol suppository imported (test) to the one locally manufactured (reference). Methods: Eighteen healthy volunteers were randomized to receive a single crossover rectal dose of test (250mg) or reference suppositories (300mg). The plasma paracetamol concentrations in both groups were determined by HPLC. Results:Based on the analysis by CRFB program, the pharmacokinetics parameters of test and reference suppositories were as follows: t1/2(3.94±1.54) vs (3.81±1.24)h; Tmax(1. 56±0.57) vs (1.58±0.43)h;MRT0-tn(5.67±1.44) vs (5.40±1.28)h;Cmax(1.73±0.38) vs (1.61±0.34)μg·mL-1; AUC0-tn(8.01±2.20) vs (7.54±1.82)h·μg·mL-1. The relative bioavailability of the test suppository was (109.07±27.92) % compared to reference suppository. The AUC0-t and Cmax of test suppository were within 97. 20%-115. 85% and 98. 64%-116. 97% of the reference suppository using the 90% confidence interval. Conclusion:The test suppository is bioequivalent to the reference suppository.