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 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
NCT ID:
NCT02618395
Eligibility Criteria:
Inclusion Criteria:
* Adult, male and female volunteers, 18 to 55 years of age
* Body mass index (BMI) ≥18 to ≤30 kg/m2 at screening
* Female subjects must have a negative serum pregnancy test
* Medically healthy on the basis of medical history and physical examination
Exclusion Criteria:
* Females who are pregnant, lactating, or likely to become pregnant during the study
* Life-time history and/or recent evidence of alcohol
* History of hypersensitivity to hydrocodone, acetaminophen or any component of the test and reference formulations
* Subjects with any condition in which an opioid is contraindicated
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02618395
Study Brief:
Protocol Section:
NCT02618395