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.