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Effect of Felbamate on the Pharmacokinetics of Lamotrigine
Author(s) -
Colucci Robert,
Glue Paul,
Holt Beverley,
Banfield Christopher,
Reidenberg Pascale,
Meehan Jeffrey W.,
Pai Sudhakar,
Nomeir Amin,
Lim Josephine,
Lin ChinChung,
Affrime Melton B.
Publication year - 1996
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/j.1552-4604.1996.tb04228.x
Subject(s) - felbamate , lamotrigine , pharmacokinetics , crossover study , cmax , placebo , anticonvulsant , medicine , bioequivalence , pharmacology , anesthesia , epilepsy , alternative medicine , pathology , psychiatry
To assess the possible interaction between lamotrigine and felbamate, a double‐blind, randomized, placebo‐controlled, two‐way crossover study was conducted in 21 healthy male volunteers. Volunteers were given lamotrigine (100 mg every 12 hours) and felbamate (1,200 mg every 12 hours) or matching placebo for 10 days during each period of the crossover. After morning administration on day 10, blood samples were obtained over 12 hours for measurement of lamotrigine. Felbamate increased the maximum concentration (C max ) and and area under the concentration‐time curve from time 0 to 12 hours (AUC 0–12 ) of lamotrigine by 13% and 14%, respectively, compared with placebo. The 90% confidence intervals of the log‐transformed pharmacokinetic parameters were within the 80–125% bioequivalence limits, however. Felbamate had no significant effect on the urinary excretion of lamotrigine (total), unconjugated lamotrigine, or the N‐glucuronide. One volunteer discontinued the study after developing a rash while taking lamotrigine and placebo. All other adverse events were primarily related to the central nervous system and gastrointestinal tract, with a higher incidence reported during coadministration of lamotrigine and felbamate than with placebo. Overall, felbamate appears to have no clinically relevant effects on the pharmacokinetics of lamotrigine.