Test of bioequivalence
6MP pharmacokinetic parameters such as Cmax, AUC0-t, AUC0-∞, Tmax, AUC_% Extrap_obs, t1/2, and Kel were calculated using plasma concentration versus time profile data of the investigational products in individual subjects using Non-Compartment Model of Phoenix WinNonlin® version 8.2 (Certara USA, Inc., Princeton, NJ). The ln-transformed pharmacokinetic parameters were analysed by analysis of variance (ANOVA) using PROC GLM in SAS Software, Version 9.4. Bioequivalence was concluded if the 90% CI of the GMR for the AUC0-t and AUC0-∞ of 6MP was entirely within the bioequivalence limits of 0.80 – 1.25 (80.00% - 125.00%). Cmax was not considered for establishing bioequivalence as the traditional suspension formulations have achieved higher peak plasma concentrations compared to solid dosage forms.