A Randomized Crossover Study to Determine the Pharmacokinetics of Intranasally Administered Acetaminophen in Healthy Adults

• Status: Withdrawn
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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 groups obtained at various times after study drug administration.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborators: American College of Medical Toxicology; McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

• Healthy volunteers 18 to 45 years of age

Exclusion Criteria:

• 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