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

January 17, 2019 updated by: University of Texas Southwestern Medical Center
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum acetaminophen levels
Time Frame: 8 hours
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

February 27, 2009

First Submitted That Met QC Criteria

February 27, 2009

First Posted (Estimate)

March 3, 2009

Study Record Updates

Last Update Posted (Actual)

January 22, 2019

Last Update Submitted That Met QC Criteria

January 17, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 052008-076

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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