Effects of steady-state bupropion on the pharmacokinetics of lamotrigine in healthy subjects.
OBJECTIVE
To evaluate the effect of steady-state bupropion SR sustained-release (BUP) on the pharmacokinetics of a single 100-mg dose of lamotrigine (LTG).


METHODS
Randomized, open-label, two-way crossover study


METHODS
Clinical Studies Ltd., Fort Lauderdale, Florida.


METHODS
Twelve healthy subjects.


METHODS
Treatment A: LTG 100 mg with steady-state BUP 150 mg twice/day; treatment B: LTG 100 mg.


RESULTS
The pharmacokinetics of LTG were determined by noncompartmental methods using plasma and urine concentrations. Geometric least squares mean ratios and 90% confidence intervals were calculated for treatment comparison. Safety assessments included clinical laboratory tests, vital signs, and adverse events monitoring. Pharmacokinetic parameters of LTG were not significantly different between treatments. Five subjects experienced seven mild, potentially drug-related adverse events (insomnia [2]; nausea, headache, facial pain, fatigue, and depression [1 each]) that resolved spontaneously.


CONCLUSIONS
Steady-state BUP caused no clinically relevant changes in the pharmacokinetics of a single dose of LTG.
Odishaw
J
J
Glaxo Wellcome Research and Development, Research Triangle Park, North Carolina 27709, USA.
Chen
C
C
D000328:Adult; D000927:Anticonvulsants / Q000009:adverse effects / Q000493:pharmacokinetics*; D018687:Antidepressive Agents, Second-Generation / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D016642:Bupropion / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D004347:Drug Interactions; D005260:Female; D006801:Humans; D000077213:Lamotrigine; D008297:Male; D008875:Middle Aged; D014227:Triazines / Q000009:adverse effects / Q000493:pharmacokinetics*
D000927:Anticonvulsants; D018687:Antidepressive Agents, Second-Generation; D003692:Delayed-Action Preparations; D014227:Triazines; D016642:Bupropion; D000077213:Lamotrigine