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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT01050933
Eligibility Criteria:
Inclusion Criteria:
* Men and women, age \> 18 years.
* Women must be using acceptable contraceptives, post-menopausal or surgically sterile.
* No prior smoking history.
* BMI between 16 and 30 inclusive.
* In good health as per medical history, physical exam, vital signs \& ECG.
Exclusion Criteria:
* Exposure to carbon monoxide during the 48 hours prior to the study day.
* Occupational exposure to CO.
* Significant disease that may put the volunteer at risk because of participation in the study or may influence the results of the study or the volunteer's ability to participate in the study.
* Baseline blood level of COHb \>2%.
* Patients with underlying lung disease such as asthma or COPD.
* Baseline oxygen saturation \<92% on room air.
* Planned pregnancy, already pregnant or breastfeeding.
* Participation in another clinical trial within 2 months prior to study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01050933
Study Brief:
Protocol Section:
NCT01050933