Favorite Datasets from Early Phases of Drug Research

Dose Proportionality in Elderly

Part 6 - Table 2

Six healthy elderly male and six healthy elderly female subjects (Sub) completed a three period, fixed sequence, single rising dose (200mg, 400mg, 800mg) study of Drug A. A seven day washout period separated each of the single dose administrations of Drug A.

On each of the single dosing days, blood samples were taken from each of the subjects just prior to dosing and at 1, 2, 4, 6, 8, 12, 24, 30, 48, 60, and 72 hours post dose, and then assayed for plasma levels of Drug A. From these assay values, the area-under-the-plasma-concentration-vs.-time curve, AUC (ng·hr/mL), from time 0 hours to infinity, and the maximum plasma concentration, Cmax (ng/mL), were calculated for Drug A, for each subject, in each fixed sequence, rising single dose, treatment period.

• Is there a dose response in either AUC or Cmax, for either male and/or female subjects? If so, were the dose responses proportional, greater than proportional, or less than proportional, to dose?
• Were the dose responses similar or different for males and females?
• Were the magnitudes of AUC and Cmax similar or different for males and females?