Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
NCT ID:
NCT02288312
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02288312
Study Brief:
Protocol Section:
NCT02288312