Status:
COMPLETED
Effect on Acetaminophen Metabolism by Liquid Formulations
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Harvard University
National Center for Research Resources (NCRR)
Conditions:
Acetaminophen Metabolism
Acetaminophen Poisoning
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether excipients in the liquid formulation of acetaminophen prevent the formation of the toxic metabolites of acetaminophen.
Detailed Description
Acetaminophen (APAP) poisoning is the most frequent cause of acute hepatic failure in the United States. Toxicity requires cytochrome P-450 bioactivation of APAP. Children are less susceptible to APAP...
Eligibility Criteria
Inclusion
- Healthy volunteer ages 18-40
- Not taking any chronic medications
Exclusion
- Pregnancy
- Any history of liver disease
- Frequent alcohol use (2 or more drinks more than 4 times per week)
- Unable to provide informed consent
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01246713
Start Date
December 1 2010
End Date
July 1 2012
Last Update
May 8 2017
Active Locations (1)
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1
Harvard - Thorndike Clinical Research Center at Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215