Abstract
Purpose: Disease state may contribute to alteration in drug
pharmacokinetics. The purpose of this study was to determine the effect
of non-insulin dependent diabetes mellitus (NIDDM) on the
pharmacokinetics of glipizide. Methods: An open, single-dose,
parallel design was applied to the study. Glipizide tablet (5 mg) was
administered to healthy and diabetic human volunteers after over-night
fast. Blood samples were collected, centrifuged and the plasma assayed
using a sensitive and validated reverse phase high performance liquid
chromatography (RP-HPLC) method. Various pharmacokinetic parameters
were computed from the data obtained. Results: The AUC0-∞
values for healthy and diabetic volunteers was 1878 ± 195 and 1723
± 138 ng.h/ml, respectively; these values were not significantly
different (p > 0.05). The t1/2 for healthy volunteers was 3.04±
0.27 h while that for diabetic subjects was 2.98 ± 0.16 h.
Clearance for healthy and diabetic volunteers was 0.59±0.06 and
0.64±0.05 ml/min/kg, respectively. These and other pharmacokinetic
parameters assessed were not significantly different between healthy
and diabetic volunteers (p > 0.05). Conclusion: Although glipizide
showed slightly more rapid clearance from the body of diabetic
volunteers than from healthy volunteers, this difference, like those
for other pharmacokinetic parameters, was not significant (p >
0.05).