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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Intranasal acetaminophen administration

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

Intranasal acetaminophen administration

2

Oral acetaminophen administration

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

Oral acetaminophen administration

Interventions

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Acetaminophen

Intranasal acetaminophen administration

Intervention Type DRUG

Acetaminophen

Oral acetaminophen administration

Intervention Type DRUG

Other Intervention Names

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Tylenol Paracetamol Tylenol Paracetamol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes