Bioequivalence Study of Alfuzosin Tablets in Chinese HealthyVolunteers

OBJECTIVE: To study the relative bioavailability of alfuzosin tablets in Chinesehealthy volunteers and to evaluate the bioequivalence. METHODS: A single oral dose 5mg of domestic and imported alfuzosin tablets was given to 18 healthy volunteers in a randomized cross-over study. The concentration of alfuzosin in plasma was determined by HPLC. RESULTS: The main pharmacokinetic parameters of two formulations, domestic and imported tablet, were as follows; t1/2bbbbbbbb were 3.19 ± 0.60 and 2.96 ± 0.39h; tmax were 1.89 ± 0.72 and 1.53 ± 0.40h; Cmax were 18.40 ± 5. 94 and 18.99 ± 7.39 μ g·L-1; AUC0-12 were 78.70 ±18.19 and 78.57 ± 20.46 μ g·h·L-1, AUC0-∞ were 87.45 ± 19.05and 86.34 ± 29.60 μ g·h·L-1 respectively. The relative bioavailability of AUC0-12 and AUC0-∞ were 101.14% ± 7.70% and 102.13% ±9.21%. Statistical analysis showed that the 90% confidence interval of AUC0-12 and AUC0-∞ were 96.08%-105.8% and 96.97%-106.8%, in the range of 80%-125%; So the two tablets were bioequivalent. CONCLUSION: The results suggested that the domestic and imported alfuzosin tablets were bioequivalent.