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 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT01568112
Eligibility Criteria:
Key Inclusion Criteria:
* Must give written informed consent and any authorizations required by local law
* Must have a body mass index (BMI) of between 18.0 to 34.0 kg/m\^2,inclusive.
* Ability to complete the tolerability scales by accurately using the hand-held subject reporting device
* Subjects of childbearing potential must be willing to practice effective contraception
Key Exclusion Criteria:
* History of clinically significant diseases
* History of severe allergic or anaphylactic reactions
* Intolerance to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)
* Diarrhea, constipation, abdominal pain, flushing or nausea within 28 days prior to Day 1
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
55 Years
Study:
NCT01568112
Study Brief:
Protocol Section:
NCT01568112