The pharmacokinetic characteristics of domestically produced tadalafil(1)orodispersible films in healthy male Chinese volunteers and their relative bioavailability compared with tadalafil tablets were investigated.A randomized,open-label,3-period,Latin square crossover trial under fasting conditions was performed,and 36 volunteers were randomized 1∶1∶1 to receive single oral dose of 1 film without water,1 film or tablet with water.A randomized,open label,2-period crossover trial under fed conditions was also performed,and 32 volunteers were randomized 1∶1 to receive 1 film or tablet with water.A LC-MS/MS method was used to determine the concentration of 1 in plasma.Main pharmacokinetic parameters were calculated by WinNonlin 8.1 software and the statistical analysis was conducted with SAS 9.4 software.The results showed that compared with 1 tablet,the 90％confidence intervals for the geometric mean ratios of the main pharmacokinetic parameters(cmax,AUC0→t and AUC0→ ∞)of the 1 film in the fasting state were within the range of 80％-125％.While the 90％confidence interval for the geometric mean ratio of cmax of the 1 film was not within the range of 80％-125％in the fed state.These results showed that 1 film(with or without water)was bioequivalent to 1 tablets under fasting conditions but not bioequivalent under fed conditions.
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