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

This study has been withdrawn prior to enrollment.
(Unable to obtain FDA approval)
Sponsor:
Collaborators:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
American College of Medical Toxicology
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00855049
First received: February 27, 2009
Last updated: September 23, 2010
Last verified: September 2010

February 27, 2009
September 23, 2010
April 2009
December 2009   (final data collection date for primary outcome measure)
Serum acetaminophen levels [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00855049 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Randomized Crossover Study to Determine the Pharmacokinetics of Intranasally Administered Acetaminophen in Healthy Adults
A Randomized Crossover Study to Determine the Pharmacokinetics of Intranasally Administered Acetaminophen in Healthy Adults

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.

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 rectal administration have been well studied but to date there are no published studies determining the pharmacokinetics of acetaminophen following intranasal administration. This route is currently popular among heroin users. Understanding the pharmacokinetics of nasally administered acetaminophen will help physicians address the important clinical implications of acetaminophen toxicity in this population.

Ten healthy adult volunteers age 18 to 45 years will be recruited for this pilot project. Study participants will be randomized in permuted blocks to receive either oral or intranasal administration of a standardized 500 mg dose of acetaminophen. Blood samples will be drawn from a peripheral intravenous catheter at 0, 5, 15, 30, 45, 60, 90, 120, 150, 240, 360, and 480 minutes after study drug administration and sent to the laboratory for determination of serum acetaminophen concentration. After a one week washout period, each participant will cross over to receive 500 mg of acetaminophen via the remaining route of administration in the second arm of the study. The serial acetaminophen concentrations will be utilized to perform pharmacokinetic calculations.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Pharmacokinetics
  • Drug: Acetaminophen
    Intranasal acetaminophen administration
    Other Names:
    • Tylenol
    • Paracetamol
  • Drug: Acetaminophen
    Oral acetaminophen administration
    Other Names:
    • Tylenol
    • Paracetamol
  • Experimental: 1
    Intranasal acetaminophen administration
    Intervention: Drug: Acetaminophen
  • Active Comparator: 2
    Oral acetaminophen administration
    Intervention: Drug: Acetaminophen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
10
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00855049
052008-076
No
Sing-Yi Feng, MD, University of Texas Southwestern Medical Center/Children's Medical Center
University of Texas Southwestern Medical Center
  • McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
  • American College of Medical Toxicology
Principal Investigator: Sing-Yi Feng, MD UT Southwestern/Children's Medical Center
University of Texas Southwestern Medical Center
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP