food effect and dosage form proportionality study of eslicarbazepine acetate

Conditions: Epilepsy

Summary: 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.

Eligibility criteria:
inclusion criteria: * male or female subjects aged between 18 and 55 years, inclusive. * subjects of body mass index (bmi, kg/m2) within the normal range \[4\], i.e., between 18.50 and 24.99, inclusive. * subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, and 12-lead ecg. * subjects who had clinical laboratory test results clinically acceptable at screening and admission to first treatment period. * subjects who had negative tests for hbsag, anti-hcvab and anti- hiv-1 and hiv-2 ab at screening. * subjects who had a negative screen for alcohol and drugs of abuse at screening. * subjects who were non-smokers or ex-smokers who discontinued smoking at least 3 months prior to admission. * subjects who were able and willing to give written informed consent. * (if female) she was not of childbearing potential by reason of surgery (hysterectomy or tubal ligation) or, if of childbearing potential, she used one of the following methods of contraception: intrauterine device (by the study subject) + condom (by the partner), diaphragm (by the study subject) + condom (by the partner), or spermicide (by the study subject) + condom (by the partner). * (if female) she had a negative urine pregnancy test at screening and admission to each treatment period. exclusion criteria: * subjects who did not conform to the above inclusion criteria, or * subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders. * subjects who had a clinically relevant surgical history. * subjects who had a clinically relevant family history. * subjects who had a history of relevant drug hypersensitivity. * subjects who had a history of alcoholism or drug abuse. * subjects who consumed more than 14 units of alcohol a week. * subjects who used medicines within 2 weeks of first admission that, in the opinion of the investigator, may affect the safety or other study assessments. * subjects who used any investigational drug or participated in any clinical trial within 2 months of their first admission. * subjects who had previously received eslicarbazepine acetate (esl, bia 2-093). * subjects who donated or received any blood or blood products within the previous 2 months prior to screening. * subjects who were vegetarians, vegans or have medical dietary restrictions. * subjects who could not communicate reliably with the investigator. * subjects who were unlikely to co-operate with the requirements of the study. * subjects who were unwilling or unable to give written informed consent. * (if female) she was pregnant or breast-feeding. * (if female) she was of childbearing potential and she did not used and approved effective contraceptive method or she used oral contraceptives.