DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: University of Texas Southwestern Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharmacokinetics

Intervention: Acetaminophen (Drug); Acetaminophen (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: University of Texas Southwestern Medical Center

Official(s) and/or principal investigator(s):
Sing-Yi Feng, MD, Principal Investigator, Affiliation: UT Southwestern/Children's Medical Center


This study is being done to determine the systemic absorption of nasally inhaled acetaminophen (TylenolŪ) versus orally ingested acetaminophen by comparing the serum drug concentrations of the two groups obtained at various times after study drug administration.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Serum acetaminophen levels

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.


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.


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


- 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

Locations and Contacts

UT Southwestern, Dallas, Texas 75390, United States
Additional Information

Starting date: April 2009
Last updated: September 23, 2010

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017