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.
Part 6 - Table 5 | ||||||
Relative Bioavailability Study | ||||||
Formulation I |
Formulation II |
|||||
Sub   |
Seq   |
AUC |
Cmax |
AUC |
Cmax |
|
1 |
II / I |
26763.4 |
606.9 |
14591.1 |
497.8 |
|
2 |
I / II |
21777.8 |
473.8 |
9240.0 |
286.5 |
|
3 |
II / I |
15539.3 |
473.7 |
20910.2 |
356.7 |
|
4 |
I / II |
11940.0 |
399.8 |
19810.2 |
589.7 |
|
5 |
II / I |
6598.7 |
200.9 |
7937.1 |
269.1 |
|
6 |
I / II |
12385.9 |
317.6 |
16414.3 |
301.5 |
|
7 |
I / II |
30333.8 |
1851.5 |
31154.4 |
1412.5 |
|
8 |
II / I |
10379.9 |
713.2 |
4775.2 |
168.3 |
|