Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate

NCT ID: NCT02288312

Last Updated: 2015-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2007-07-31

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 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.

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIA 2-093 800 mg fasting

Tablets 800 mg. Administration:Oral.

Group Type: EXPERIMENTAL

BIA 2-093

Intervention Type: DRUG

BIA 2-093 800 mg fed

Tablets 800 mg. Administration:Oral.

Group Type: EXPERIMENTAL

BIA 2-093

Intervention Type: DRUG

BIA 2-093 400 mg

Tablets 2 x 400 mg. Administration:Oral.

Group Type: EXPERIMENTAL

BIA 2-093

Intervention Type: DRUG

Interventions

BIA 2-093

Intervention Type: DRUG

Other Intervention Names

ESL, Eslicarbazepine acetate

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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bial - Portela C S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

BIA-2093-117

Identifier Type: -

Identifier Source: org_study_id