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 @ 2:45 PM
Ignite Modification Date:
2025-12-24 @ 2:45 PM
NCT ID:
NCT01008059
Eligibility Criteria:
Inclusion Criteria:
* Male or non-pregnant female, 18-40 yr. old
* Good general health with no remarkable medical conditions such as liver, kidney, heart, or lung failure
* BMI between 20-33
* Provide informed consent
Exclusion Criteria:
* Known history of liver or kidney disease
* Use of prescription or non prescription medications, herbals or foods known to be metabolized by or affect CYP3A (including oral birth control medications)
* Females who are pregnant or nursing
* Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)
* Direct physical access to and routine handling of addicting drugs in the regular course of duty (this is a routine exclusion from studies of drugs with addiction potential).
* History of bradycardia
* Respiratory rate \<10
* History of significant pulmonary disease
* History of pre-existing medical condition predisposing to respiratory depression
* Systolic blood pressure \<100 mgHg and diastolic blood pressure \<70mmHg
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01008059
Study Brief:
Protocol Section:
NCT01008059