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 @ 5:20 PM
Ignite Modification Date:
2025-12-26 @ 5:20 PM
NCT ID:
NCT00813306
Eligibility Criteria:
Inclusion Criteria:
* Provision of written consent prior to any study specific procedures.
* Healthy subjects, age 18-45 years inclusive. Females must be of no childbearing potential or must use a highly effective contraceptive method.
* Clinically normal physical findings and laboratory values at the time of pre-entry visit, as judged by the investigator.
Exclusion Criteria:
* Clinically significant illness within the 2 weeks prior to the first dose of the investigational product, including a suspected/manifested infection according to WHO risk categories 2, 3 or 4, as judged by the investigator.
* A measured LES pressure of \< 5mm Hg.
* History of previous or ongoing psychiatric disease/condition.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00813306
Study Brief:
Protocol Section:
NCT00813306