Pharmacokinetics and Relative Bioavailability of Tadalafil Orodispersible Films in Healthy Volunteers
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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