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

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00855049
• Other study ID #: 052008-076
• Status: Withdrawn
• Phase: N/A
• Start date: April 2009
• Est. completion date: December 2009

Study information

• Verified date: January 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• Acetaminophen
Intranasal acetaminophen administration
• Acetaminophen
Oral acetaminophen administration

Locations

Country	Name	City	State
United States	UT Southwestern	Dallas	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	American College of Medical Toxicology, McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum acetaminophen levels		8 hours