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Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate Market Formulation in Healthy Volunteers
Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence study in 18 healthy male and female subjects.
Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence study in 18 healthy male and female subjects. The study consisted of 3 periods separated by a washout of 7 days or more between doses. Subjects received a single oral 800 mg dose of eslicarbazepine acetate following a standard meal in one period, and following at least 10 hours of fasting in two periods.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
Yes
Start Date
May 1, 2007
Primary Completion Date
July 1, 2007
Completion Date
July 1, 2007
Last Updated
January 8, 2015
18
ACTUAL participants
BIA 2-093
DRUG
Lead Sponsor
Bial - Portela C S.A.
NCT06700356
NCT02531880
NCT05871372
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