Status:
WITHDRAWN
A Randomized Crossover Study to Determine the Pharmacokinetics of Intranasally Administered Acetaminophen in Healthy Adults
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
American College of Medical Toxicology
Conditions:
Pharmacokinetics
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
This study is being done to determine the systemic absorption of nasally inhaled acetaminophen (Tylenol®) versus orally ingested acetaminophen by comparing the serum drug concentrations of the two gro...
Detailed Description
This study is aimed at addressing a significant void in the current literature regarding nasally administered acetaminophen pharmacokinetics. The pharmacokinetics of acetaminophen following oral and r...
Eligibility Criteria
Inclusion
- Healthy volunteers 18 to 45 years of age
Exclusion
- Known hypersensitivity to acetaminophen
- Prior dosing of acetaminophen or product containing acetaminophen in the preceding 7 days
- Hepatic insufficiency and/or failure, or any known liver disease
- History of nasal polyps
- History of nasal trauma in past 14 days
- History of nasal bleeding in past 14 days
- History of asthma, emphysema or any serious respiratory diseases
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00855049
Start Date
April 1 2009
End Date
December 1 2009
Last Update
January 22 2019
Active Locations (1)
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1
UT Southwestern
Dallas, Texas, United States, 75390