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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT02465866
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Subject's body mass index (BMI) must be between 18 and 30kg/m2 (inclusive), and subject must weigh a minimum of 50 kg (110lb)
* Abide by study restrictions
* Acceptable birth control measures
* Ability to attend all study visits
* Vital signs as per protocol
* Willing to consume high calorie meals within designated time frame
Exclusion Criteria:
* Clinically significant medical history
* Clinically significant abnormal findings
* History or presence of allergic or adverse response to hydrocodone, ibuprofen,acetaminophen, any non-steroidal anti-inflammatory drugs (NSAIDs), promethazine, or related drugs.
* Has smoked or used tobacco products within 60 days prior to the first dose of study medication
* Has donated blood or plasma within 30 days prior to the first dose of study medication
* Has participated in another clinical trial (randomized subjects only) within 30 days prior to the first dose of study medication.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02465866
Study Brief:
Protocol Section:
NCT02465866