Non-compartmental and population pharmacokinetic analysis of dapsone in healthy NIGERIANS: A pilot study

Dapsone is employed for both non-dermatological and dermatological indications but with non-existent population pharmacokinetics (popPK) data in Nigerians. This study was therefore designed to develop a popPK model in Nigerians. Non-compartmental analysis and nonlinear mixed effects modelling were utilized for data analysis. Eleven participants administered 50 mg dapsone tablet were included in the analysis. Derived pharmacokinetic parameters were: C-max = 1.16 & PLUSMN; 0.32 & mu;g/mL, T-max = 3.77 & PLUSMN; 2.40 h, and t(1/2z) = 30.23 & PLUSMN; 11.76 h. PopPK model parameter estimates with inter-individual variability were Tlag = 0.40 h (10.0%, fixed); k(a) = 1.78 h(-1) (75.9%); V/F = 89.25 L (21.6%); and Cl/F = 1.32 Lh(-1) (27.7%). Sex was significantly associated with Cl/F, and body weight with V/F. Best popPK model was one-compartment with lag time, and first-order absorption and elimination. Sex and body weight significantly influenced the clearance and distribution volume of dapsone respectively.