Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol® Extend

November 20, 2014 updated by: GlaxoSmithKline

A Single Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Different Sustained Released Paracetamol Formulations

This study will evaluate the pharmacokinetic profiles of experimental formulations of paracetamol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68501
        • MDS Pharma Services NEBRASKA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Good health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination

Exclusion Criteria:

  • Current (within 14 days of screening) or regular use of any prescription, over the counter (OTC) drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism, excluding prescription birth control, if applicable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Marketed paracetamol
Marketed formulation
Drug: Marketed paracetamol
marketed formulation
EXPERIMENTAL: Experimental paracetamol formulation
Experimental formulation
Drug: Experimental paracetamol formulation
Experimental formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bioavailability as measured by Area Under the Curve (AUC) in both fasted and fed state
Time Frame: baseline to 12 hours
baseline to 12 hours
Effect of food on the extent and rate of paracetamol absorption as measured by AUC and Cmax
Time Frame: baseline to 12 hours
baseline to 12 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess descriptive pharmaokinetic characteristics (Tmax, T1/2, Cmax, AUC)
Time Frame: baseline to 12 hours
baseline to 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

February 23, 2012

First Submitted That Met QC Criteria

February 23, 2012

First Posted (ESTIMATE)

February 29, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 24, 2014

Last Update Submitted That Met QC Criteria

November 20, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2750605

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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