Safety

 

The adverse effect profiles during the test and reference periods were similar.  Approximately 12% of subjects in either the test or reference periods experienced a drug-related adverse event.  Adverse events included headache, hand numbness, tremor, pruritis, and nausea and vomiting.  Two subjects withdrew from the study due to adverse events. In one case the subject had swelling, pain, stiffness, and numbness in the right hand, and in the other case the subject had contusion at the venipuncture site and upper limb that were considered to be unrelated to the study drug or unlikely related to the study drug.

 

CONCLUSIONS:

 

Although the 90% Confidence interval is not contained in the equivalence limits of 80%-125% for 2 of the metabolites of bupropion, the differences between the fed and fasting states are very small (≤15%).  Therefore, this study demonstrates that there is no appreciable effect of food on exposure to bupropion or its metabolites when bupropion extended release tablets (300 mg) are given with a high fat meal.

 

Stamped: Appears This Way On Original

 

 

73

 

 

 

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