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:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
NCT ID:
NCT01368016
Eligibility Criteria:
Inclusion Criteria:
* Healthy subjects, smoking more than 20 cigarettes daily during at least one year preceding inclusion.
* Body Mass Index (BMI) between 17.5 and 32.0 kg/m2 and a total body weight of at least 55.0 kg.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
Exclusion Criteria:
* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product within one month preceding the first dose of study medication.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT01368016
Study Brief:
Protocol Section:
NCT01368016