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 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT00714558
Eligibility Criteria:
Inclusion Criteria:
* Healthy, non smoker, men and nonpregnant nonlactating women
* Weighing a minimum of 60 kg and were within 15% of ideal weight for height as described in the Metropolitan Life Insurance Height and Weight Standards
* Who did not have a history or show presence of drug or alcohol dependence or abuse
* And who had, after sitting for 5 minutes, blood pressure between the ranges of 100 to 150 mm Hg systolic and 50 to 90 mm Hg diastolic. Any decrease in systolic blood pressure after standing for 2 minutes had to be less than or equal to 20 mm Hg
Exclusion Criteria:
* History of chronic obstructive pulmonary disease or any other lung disease, such as asthma, that would cause carbon dioxide retention
* Known allergy or hypersensitivity to fentanyl or other opioids, naltrexone or naloxone
* Usage of prescription medication (except for birth control medications, sex-hormone replacement or vitamins) within 14 days before Day 1, monoamine oxide inhibitors within 21 days prior to Day 1, over-the-counter medication (except for vitamin supplements or acetaminophen less than 2 gm/day) or herbal medication within 3 days prior to Day 1, alcohol, grapefruit juice, or caffeine within 48 hours before dosing
* Consumption of more than 450 mg of caffeine per day (eg, approximately 5 cups of tea, 3 cups of regular coffee, or 8 cans of cola)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00714558
Study Brief:
Protocol Section:
NCT00714558