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 @ 3:10 AM
Ignite Modification Date:
2025-12-25 @ 3:10 AM
NCT ID:
NCT02068105
Eligibility Criteria:
Inclusion Criteria:
* Be in good physical health
* Body mass index of 18-30 kg/m2
* Agree to use an approved method of birth control for the duration of the study
* Additional criteria may apply
Exclusion Criteria:
* Currently pregnant or breastfeeding
* History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV)
* Current or history of any clinically significant medical or psychiatric condition
* Current abuse or dependence on alcohol or any illicit drugs
* Have used nicotine within 90 days
* Have used St. John's Wort or consumed grapefruit, grapefruit juice, or juices containing grapefruit within 30 days
* Have used any prescription or over-the-counter medication, including natural health products (with the exception of prescription birth control or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days
* Have used opioids 30 days prior to screening or have an anticipated need for opioid medication at any point during the study
* Have a history of intolerance or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
* Additional criteria may apply
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02068105
Study Brief:
Protocol Section:
NCT02068105