ASSAY:

 

Table 3.  Performance of Analytical Method for AK1BIOVAIL2543

Analyte	Method	Range (ng/ml)	Linearity	LOQ (ng/ml)	QC (ng/ml)	Inter-day CV (%)	Inter-day Accuracy (%)
Bupropion	LC/MS/MS	[blacked out]	[blacked out]	[blacked out]	[blacked out]	6.0 3.8 3.4 3.5	[blacked out]
Bupropion Erythroamino alcohol	LC/MS/MS	[blacked out]	[blacked out]	[blacked out]	[blacked out]	8.2 4.7 3.9 3.5	[blacked out]
Bupropion Threoamino alcohol	LC/MS/MS	[blacked out]	[blacked out]	[blacked out]	[blacked out]	10.2 5.3 4.1 3.7	[blacked out]
Hydroxybupropion	LC/MS/MS	[blacked out]	[blacked out]	[blacked out]	[blacked out]	6.9 3.7 3.3 3.6	[blacked out]

 

Two calibration curves and duplicate QC samples were analyzed with each batch of study sample study samples were stored at  -70°C.  Samples were analyzed within the period for which the samples are stable at -70°C.  Methanolic solutions of bupropion and metabolites were used within the period for which they were stable.  The performance of the assays for all analytes is considered acceptable.

 

RESULTS:

Demographics:

Forty subjects (27 males and 13 females) were enrolled in the study.  The mean age of the subjects was 32.9 years of age, and the range was 20 to 50 years old.  Thirty subjects completed the entire study and were eligible for pharmacokinetic analysis.  Nine subjects discontinued form the study due to adverse events and a 10^th subject declined to participate further after Day 6 of Period 1.

 

Table 4. Demographics of Subjects Completing the Study

Mean Age (Range)	Gender	Weight (mean ± SD)	Race
34 (20-50)	22 males 8 females	72.10 ± 10.0 kg (n=30)	Asian        2 Black        10 Caucasian  18

 

Pharmacokinetics

 

In addition to evaluate of the pharmacokinetics of the parent compound and its active metabolites, the pharmacological activity-weighted composite (PAWC) was also evaluated.  The

 

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