of the subjects experienced a drug-related adverse event (57% while receiving the test product and 63% while receiving the reference product). The most common adverse events that led to premature discontinuation of the investigation product or the study were skin events including rash and pruritis that were considered mild to moderate in severity. Other adverse events in the subjects who discontinued the study included dysuria or urinary urgency, dizziness, and nausea. One subject had chest pain and an abnormal ECG that were considered to be unlikely related to study medication.
CONCLUSIONS:
This
study demonstrated equivalence between bupropion extended release (Test) 300 mg
tablets and WELLBUTRIN immediate release (Reference) tablets (100 mg tid) after
multiple dosing at steady state under fasting conditions for all comparisons
except for Cmin for the parent compound. Consideration should be given to the active metabolites, since
they account for approximately 90% of the systemic exposure. Since the two products are bioequivalent in
terms of the metabolites and for Cmax and AUC of the parent bupropion,
it is reasonable to suggest that the two products are comparable in exposure.
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