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 @ 4:50 AM
Ignite Modification Date:
2025-12-25 @ 4:50 AM
NCT ID:
NCT00616018
Eligibility Criteria:
Inclusion Criteria:
1. age 21 years or older
2. provide written informed consent
3. consume, on average, less than 1 alcoholic beverage daily for the previous 3 months and would be considered non-drinkers
Exclusion Criteria:
1. History of ingesting more than 4 grams of acetaminophen per day for any of the 4 days preceding study enrollment
2. Currently taking isoniazid
3. Consumption of any alcoholic beverage during the run-in period
4. A detectable serum acetaminophen at baseline
5. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 50 IU/L at the start of the run-in period or at baseline
6. Platelet count less than 125,000/cc at baseline
7. Positive pregnancy test at baseline (female participants only)
8. Currently adheres to a fasting type diet as determined by self report
9. Currently has anorexia nervosa as determined by self report
10. Subject appears clinically intoxicated, psychiatrically impaired or unable to give informed consent for any reason
11. Known hypersensitivity to acetaminophen
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00616018
Study Brief:
Protocol Section:
NCT00616018