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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT01738503
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects
* Agree not to take any buprenorphine products other than those administered for the current study throughout participation in the study
* Body mass index (BMI) of \>18.0 to \< 33.0 kg/m
Exclusion Criteria:
* Participants with a current diagnosis requiring chronic opioid treatment
* Participants with a history of risk factors of Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) or an ECG demonstrating a Fridericia's corrected QT interval (QTcF) \>450 msec in males and QTcF \> 470 in females at screening
* Abuse of buprenorphine or use of buprenorphine within 14 days of informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01738503
Study Brief:
Protocol Section:
NCT01738503