Favorite Datasets from Early Phases of Drug Research

Relative Bioavailability Study

Part 6 - Table 5

Eight healthy male subjects (Sub) were allocated randomly to one of two treatment sequences (Seq) in a two period crossover study in which two formulations, I and II, of Drug P were evaluated for similarity (+/- 50%) in bioavailability. In the first treatment sequence (I/II), Formulation I was given in the first treatment period followed by Formulation II in the second treatment period. The reverse ordering (II/I) was given in the second treatment sequence. A washout period separated the treatment periods.

Two pharmacokinetic variables, area-under-the-plasma-concentration-vs.-time curve, AUC (ng·hr/mL), and maximum plasma concentration, Cmax (ng/mL), were calculated for each subject in each treatment period from plasma samples taken at pre dose and several time points post dose.

• Are the average bioavailabilities of Formulations I and II within 50%?
• Are there any individual subjects whose results differ from the others?
• Do the conclusions from normal theory and distribution – free / nonparametric analyses of the data agree?