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 @ 6:30 PM
Ignite Modification Date:
2025-12-24 @ 6:30 PM
NCT ID:
NCT00439868
Eligibility Criteria:
Inclusion Criteria:
* Healthy males or females.
* Non-smokers
* Agree to remain in the clinic for the time defined in the protocol.
* Normal ECG.
Exclusion Criteria:
* Any serious medical disorder or condition.
* Any history of an endocrine disorder.
* Any clinically significant laboratory abnormality.
* History of psychiatric illness.
* Any history of suicidal attempts or behavior.
* Risk factors for precipitation of angle closure glaucoma or elevated IOP.
* Inability to refrain from use of contact lenses during the study days, if correction is required.
* Self-administered Beck Depression Inventory II scale total score greater than 9, and a suicide question score of greater than zero.
* Current or past history of seizure disorder or brain injury (traumatic or disease-related); or any condition which, in the opinion of the investigator, predisposes to seizure - Women having a positive serum HCG pregnancy test at screening, a positive urine pregnancy test before admission to the Unit during the in-house periods, who are not willing to use acceptable methods of contraception or who are lactating or planning to become pregnant within the three months following the screening visit.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00439868
Study Brief:
Protocol Section:
NCT00439868