RESULTS:

 

Demographics:

 

Thirty-six subjects (19 males and 17 females) were enrolled in the study and received investigation product.  The mean age of the subjects was 34.2 years of age, and the range was 19 to 55 years old.  One subject withdrew from personal reasons.  Thirty-five subjects completed the study and were eligible for pharmacokinetic analysis.  The demographics of the thirty-five subjects included in the pharmacokinetic analysis population are shown below.

 

Table 4.  Demographics of Subjects Included in the Pharmacokinetic Analysis Population

Mean Age (Range)	Gender	Weight (mean ± SD)	Race
34.3 (19-55)	19 males 16 females	72.9 ± 11.2 kg (n=35) 79.3 ± 10.4 kg (male) 65.4 ± 6.5 kg (female)	Asian        4 Black        4 Caucasian 27

 

Pharmacokinetics:

 

In addition to evaluation of the pharmacokinetics of the parent compound and its active metabolites, the pharmacological activity-weighted composite (PAWC) was also evaluated.  The PAWC was calculated by dividing the measured concentrations by the respective molecular weight of each moiety followed by multiplication by the previously determined relative potency in an animal model of antidepressant activity.  The sum of the resultant values represents the PAWC.

 

Pharmacokinetic parameters were determined using noncompartmental analysis.  The plasma concentration time course and the pertinent pharmacokinetic parameters (proved by Sponsor) for bupropion, its metabolites, and the PAWC are shown in Figure 1 and Tables 5 and 6, below.

 

Stamped: Appears This Way On Original

 

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