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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00855049
Recruitment Status : Withdrawn (Unable to obtain FDA approval)
First Posted : March 3, 2009
Last Update Posted : September 27, 2010
Information provided by:

Study Description
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 groups obtained at various times after study drug administration.

Condition or disease Intervention/treatment
Pharmacokinetics Drug: Acetaminophen

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 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized Crossover Study to Determine the Pharmacokinetics of Intranasally Administered Acetaminophen in Healthy Adults
Study Start Date : April 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Intranasal acetaminophen administration
Drug: Acetaminophen
Intranasal acetaminophen administration
Other Names:
  • Tylenol
  • Paracetamol
Active Comparator: 2
Oral acetaminophen administration
Drug: Acetaminophen
Oral acetaminophen administration
Other Names:
  • Tylenol
  • Paracetamol

Outcome Measures

Primary Outcome Measures :
  1. Serum acetaminophen levels [ Time Frame: 8 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855049

United States, Texas
UT Southwestern
Dallas, Texas, United States, 75390
Sponsors and Collaborators
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
More Information

Responsible Party: Sing-Yi Feng, MD, University of Texas Southwestern Medical Center/Children's Medical Center
ClinicalTrials.gov Identifier: NCT00855049     History of Changes
Other Study ID Numbers: 052008-076
First Posted: March 3, 2009    Key Record Dates
Last Update Posted: September 27, 2010
Last Verified: September 2010

Keywords provided by University of Texas Southwestern Medical Center:

Additional relevant MeSH terms:
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs