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Dear All,
Has anyone experience with Bioequivalence Studies of Lamotrigine?
I would like to know if N = 24 subjects (single dose, crossover)
would be adequate to perform this study or if this drug has a high
variable disposition with CV (intra subject) higher than 30% to AUC
and/or Cmax.
Regards,
Daniel Rossi de Campos
Brazil
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Dear Daniel,
PK of Lamotrigine is quite predictable from even a small BE study. We
had 2 studies one using 12 subjects and another using 28. Results
from both the studies were almost similar.
Hope this helps.
Regards
Manoj K. Paruthi
Manager, R&D
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Dear Daniel,
We have studied the relative bioavailability of two different
lamotrigine formulations (chewable dispersible tablets and the
compressed tablets). Each study was a single dose, crossover design
(N=12) giving a lamotrigine formulation by two different routes (oral
versus rectal). I have included the citations below in case you
would like more detail on these studies.
AK Birnbaum, RL Kriel, RT Burkhardt, RP Remmel, Rectal Absorption of
Lamotrigine Compressed Tablets, Epilepsia 41 (7):850-853 (2000).
AK Birnbaum, RL Kriel, Y Im, RP Remmel, Relative Bioavailability of
Lamotrigine Chewable Dispersible Tablets, Pharmacotherapy 21(2):
158-162 (2001).
Angela
--
Angela Birnbaum, Ph.D.
Associate Professor
Epilepsy Research and Education Program
Experimental and Clinical Pharmacology
University of Minnesota
7-170 WDH
308 Harvard St., SE
Minneapolis, MN 55455
Phone: 612-624-3158
Fax: 612-626-0148
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