Status:
COMPLETED
Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
Epilepsy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence study in 18 healthy male and female subjects.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02288312
Start Date
May 1 2007
End Date
July 1 2007
Last Update
January 8 2015
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