Safety

 

According to the Sponsor, four of six subjects experienced at least one adverse event, and all adverse events were considered mild to moderate.  Adverse events considered related to study drug include dizziness, somnolence, headache, and vomiting.

 

CONCLUSIONS

 

PET studies with ¹¹C-CIT-FE demonstrated approximately 26% occupancy of the dopamine transporter in the striatum up to 24 hours following the last dose of bupropion given as WELLBUTRIN SR, 150 mg every 13 hours, that is a clinically relevant dose.  Future efforts would be required to evaluate the effects on the noradrenaline transporter, and to characterize the relationship between occupancy and clinical effect, in order to provide a link between dose, pharmacokinetics, and effect as well as to further characterize the mechanism for the effect.

 

Stamped: Appears This Way On Original

 

 

 

66

 

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