A Pharmacokinetic Study of an Experimental Paracetamol Formulation

November 20, 2014 updated by: GlaxoSmithKline

A Pivotal Pharmacokinetic Study Investigating the Extent of Absorptions of Paracetamol and Caffeine for Two Different Paracetomol Formulations Containing Caffeine

This PK study is designed to show bioequivalence between the study treatments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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
    • Arizona
      • Phoenix, Arizona, United States, 85044
        • MDS Pharma Services ARIZONA

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:

  • Healthy volunteer

Exclusion Criteria:

-

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental paracetamol formulation
experimental formulation
Drug: Experimental paracetamol
experimental paracetamol with caffeine
Active Comparator: paracetamol marketed formulation
Paracetamol marketed formulation
Drug: Paracetamol marketed formulation
marketed formulation containing caffeine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PK variables (AUC 0-10hrs, AUC 0-inf, and Cmax) to determine bioequivalence
Time Frame: 10 hours
10 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
PK variables to compare speed of absorption (AUC 0-30min, AUC 0-60min, Tmax)
Time Frame: 10 hours
10 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

July 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

November 17, 2011

First Submitted That Met QC Criteria

November 17, 2011

First Posted (Estimate)

November 22, 2011

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

  • A2260665

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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