Favorite Datasets from Early (and Late) Phases of Drug Research

Bioequivalence Study

Part 5 - Table 2

Sixteen healthy human male subjects (Sub) were allocated randomly to one of two treatment sequences (Seq) in a two period crossover design. The objective of the trial was to determine if the pharmacokinetic characteristics of a new rapidly dissolving wafer (RPD) are the same as a tablet (CT) formulation. The two treatment sequences were either RPD in the first period followed by CT in the second period, or the reverse order. A seven day washout period separated the two treatment periods.

On each day of dosing, blood samples were taken from each of the subjects prior to dosing and at 15, 30, 45, 60, and 90 minutes and 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours postdose. From these measurements, the area under the plasma concentration vs. time curve (AUC) from zero to 48 hours (ng×hr/mL), the maximum plasma concentration (Cmax, in ng/mL), and the time of Cmax (Tmax, in hours), were estimated for each formulation (RDP and CT) for each subject.

• As measured by AUC, Cmax, and Tmax, is the RPD formulation pharmacokinetically equivalent to the CT formulation?
• Are there any subjects whose results exert an unusually large influence on the outcome of the statistical analysis?
• Are there any period or sequence effects, or treatment-by-period interactions?