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:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT02171234
Eligibility Criteria:
* Inclusion Criteria:
* Adult males aged 18-45 years, with a body mass index (BMI) of 19-28 kg/m2.
* Subjects who were healthy as determined by pre-study medical history, physical examination, 12-lead ECG and EEG.
* Subjects who had clinical laboratory tests acceptable to the investigator.
* Subjects who were negative for HbsAg, anti-HCV and HIV I and II tests at screening.
* Subjects who were negative for drugs of abuse and alcohol tests at screening and admission.
* Subjects who were non-smokers or previous smokers who had not smoked for at least 6 months.
* Subjects who were able and willing to give written informed consent.
* Exclusion Criteria:
* Subjects who did not conform to the above inclusion criteria.
* Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, 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 atopy.
* Subjects who had a history of relevant drug hypersensitivity (carbamazepine and
* related compounds).
* Subjects who had a history of alcoholism.
* Subjects who had a history of drug abuse.
* Subjects who consumed more than 28 units of alcohol a week.
* Subjects who had a significant infection or known inflammatory process on screening and/or admission.
* Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn).
* Subjects who had an acute infection such as influenza at the time of screening and/or admission.
* Subjects who had used prescription drugs within 4 weeks of first dosing.
* Subjects who had used over the counter medication, excluding routine vitamins but including mega dose vitamin therapy, within one week of dosing.
* Subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of admission to this study.
* Subjects who had donated and/or received any blood or blood products within 3 months prior to screening.
* Subjects who were vegetarians, vegans and/or had 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.
* Subjects who had previously received BIA 2-093.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02171234
Study Brief:
Protocol Section:
NCT02171234