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

NCT00855049 | Withdrawn

• 1 other identifier: 052008-076
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pharmacokinetics

Keywords

Pharmacokinetics; Acetaminophen; Intranasal; Absorption

Outcome Measures

Primary Outcomes (1)

• Serum acetaminophen levels

  8 hours

Study Arms (2)

1

EXPERIMENTAL

Intranasal acetaminophen administration

Drug: Acetaminophen

2

ACTIVE COMPARATOR

Oral acetaminophen administration

Drug: Acetaminophen

Interventions

Acetaminophen DRUG

Intranasal acetaminophen administration

Also known as: Tylenol, Paracetamol

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers 18 to 45 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.: collaborator
• American College of Medical Toxicology: collaborator

Study Sites (1)

UT Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sing-Yi Feng, MD

  UT Southwestern/Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 27, 2009
• First Posted: March 3, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 22, 2019

Record last verified: 2019-01

Locations

US (1)