Glipizide Pharmacokinetics in Healthy and Diabetic Volunteers.

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). [ABSTRACT FROM AUTHOR]