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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This study has been withdrawn prior to enrollment.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
History of Changes
  Purpose

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 Intervention
Pharmacokinetics
 Drug: Acetaminophen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Randomized Crossover Study to Determine the Pharmacokinetics of Intranasally Administered Acetaminophen in Healthy Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Serum acetaminophen levels [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: April 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855049

Locations
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
Investigators
Principal Investigator: Sing-Yi Feng, MD UT Southwestern/Children's Medical Center
  More Information

No publications provided

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
Study First Received: February 27, 2009
Last Updated: September 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Pharmacokinetics
Acetaminophen
Intranasal
Absorption

Additional relevant MeSH terms:
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013