Pharmacokinetic parameters
The mean pharmacokinetic
parameters estimated for Reference product (R) and Test product (T) are
depicted in Table 1. The geometric least squares mean of Test
Formulation (T) and Reference Formulation (R), its ratio (T/R)%,
intra-subject variability, 90% confidence intervals the Geometric least
square mean ratio (T/R) and power obtained from the analysis of
ln-transformed parameters AUC0-t and
AUC0-∞ are summarized in Table 2 The GMR (90% CI) of
the AUClast between the test and the reference
formulations was 1.46 (1.37–1.55). Thus, the test product (6
Mercaptopurine 10 mg/mL (at a dose of 5 mL = 50 mg) did not meet the
bioequivalence criteria as the bioavailability of suspension was 46%
higher compared to the tablet.