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 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT01615393
Eligibility Criteria:
Inclusion Criteria:
* Adult healthy volunteers, 18 to 55 years of age
* Clinically healthy as confirmed by medical history, physical examination, electrocardiogram, thorax teleradiography and routine clinical laboratory measurements
* Body mass index between 18 and 28 kg/m2
* Negative testing for drugs of abuse
Exclusion Criteria:
* History or presence of any clinically significant condition that might interfere with the pharmacokinetics of the study drugs
* Volunteers require co-medications during the study
* Exposure to agents known as inducers or inhibitors of hepatic enzymatic system within 30 days prior to study start
* Having taken any medication with a clearance period of over seven half-life before study start
* Hospitalization or significant illness 30 days before study start
* Having received a investigational drug within 90 days prior to study start
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01615393
Study Brief:
Protocol Section:
NCT01615393