A Randomized Crossover Study to Determine the Pharmacokinetics of Intranasally Administered Acetaminophen in Healthy Adults
Information source: University of Texas Southwestern Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pharmacokinetics
Intervention: Acetaminophen (Drug); Acetaminophen (Drug)
Phase: N/A
Status: Not yet recruiting
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
Overall contact:
Ashley Negaard, Phone: 214-456-0195, Email: ashley.negaard@UTSouthwestern.edu
Summary
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: Basic Science, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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
Locations and Contacts
Ashley Negaard, Phone: 214-456-0195, Email: ashley.negaard@UTSouthwestern.edu
UT Southwestern, Dallas, Texas 75390, United States
Additional Information
Starting date: April 2009
Ending date: December 2009
Last updated: February 27, 2009
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