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:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT03090568
Eligibility Criteria:
Inclusion Criteria:
* aged between 18 and 45 years, inclusive.
* had a body mass index (BMI) between 19 and 30 kg/m2, inclusive.
* were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
* had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
* had clinical laboratory test results clinically acceptable at screening and admission to the first treatment period.
* had negative screen for alcohol and drugs of abuse at screening and admission to the first treatment period.
* were non-smokers or smoked ≤ 10 cigarettes or equivalent per day.
* was able and willing to give written informed consent.
Exclusion Criteria:
* 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.
* had a clinically relevant surgical history.
* had a clinically relevant family history.
* had a history of relevant atopy or drug hypersensitivity.
* had a history of alcoholism or drug abuse.
* consumed more than 14 units of alcohol a week.
* had a significant infection or known inflammatory process at screening or admission to the first treatment period.
* had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to the first treatment period.
* used medicines within 2 weeks of admission to first period that affected the safety or other study assessments, in the investigator's opinion.
* used any investigational drug or participated in any clinical trial within 3 months prior to screening.
* participated in more than 2 clinical trials within the 12 months prior to screening.
* donated or received any blood or blood products within the 3 months prior to screening.
* was a vegetarian, vegan or with medical dietary restrictions.
* could not communicate reliably with the investigator.
* was unlikely to co-operate with the requirements of the study.
* was unwilling or unable to give written informed consent.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03090568
Study Brief:
Protocol Section:
NCT03090568