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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.

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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

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Last modified September 4, 2011 - THS