EFFECT OF FOOD AND GENDER ON THE PHARMACOKINETICS OF TUCARESOL IN HEALTHY-VOLUNTEERS

Aims The potential effects of food and gender on the pharmacokinetics of tucaresol were investigated in healthy volunteers. Methods Ten male s (mean weight 76.5 kg, age 27-42 years) and eight females (mean weigh t 58.9 kg, age 18-44 years) received a single oral dose of 200 mg tuca resol on two occasions in random order. On one occasion, tucaresol was given after an overnight fast and on the other, immediately after ing estion of a standard breakfast. Results There were no significant diff erences in standard pharmacokinetic parameters between the two occasio ns but the rate of tucaresol absorption was faster after food intake. Female subjects had higher C-max (ratio 1.25 with 95% CI 1.10-1.44) an d AUC (ratio 1.25 with 95% CI 1.05-1.49) values than males but the dif ferences were due to the higher body weights of the males; weight-adju sted apparent total clearance values (CL/F) were not different between genders (ratio 1.03 with 95% CI 0.87-1.21). Conclusions Food intake a nd gender have no significant effect on the exposure to orally adminis tered tucaresol.