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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT01917760
Eligibility Criteria:
Inclusion Criteria:
1. Volunteers in good health condition between 19 and 40 years of age (inclusive) at the time of signing the informed consent.
2. Body mass index (BMI) between 18.5 and 24 kg/m2 (inclusive), with weight greater than 50 kg.
3. Not on any medication 2 weeks before screening.
4. No blood donation within 3 months before screening.
5. Must sign the informed consent. Note: Blood and biochemical tests must be normal during the screening. However, if the participant's test-results were beyond the normal range, the individual can still be recruited as long as the results do not affect the experiment.
Exclusion Criteria:
1. Abnormalities of physical examination, laboratory tests, or ECG in screening, which may influence the results of the study.
2. Previous or existing history of severe heart, liver, kidney, gastrointestinal, nervous system, mental, or metabolic abnormalities as well as other diseases which can affect drug absorption, circulation, metabolism, or excretion.
3. History of alcoholism, smoking, or drug abuse within the past 1 year.
4. Participation in any clinical drug study within the past 30 days.
5. Any definite or suspected allergy or family history of allergy to GABA or any other similar drugs.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
40 Years
Study:
NCT01917760
Study Brief:
Protocol Section:
NCT01917760