A Study to Compare Two Paracetamol Tablets

July 5, 2016 updated by: GlaxoSmithKline

A Single Dose Pharmacoscintigraphic Study Investigating the Differences in Gastrointestinal Behavior and Paracetamol Absorption Between Sustained Release Formula and Standard Release Formula

This is a single dose pharmacoscintigraphic study investigating the differences in paracetamol absorption between two formulations.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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 Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom, G63 0BX
        • BIO-IMAGES Research Ltd.
      • Glasgow, Scotland, United Kingdom, G63 0BX
        • Bio-Images

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

Male

Description

Inclusion Criteria:

  • Healthy male subjects who are in good general health
  • Have not exceeded the limits of total radiation exposure (5mSv) allowed in any 12 month period

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
Time of onset and completion of disintegration based on release of radiolabeled markers in a fed condition
Time Frame: Baseline to 12 hours post dosing
Baseline to 12 hours post dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the gastrointestinal transit by qualitative scintigraphic analysis
Time Frame: Baseline to 12 hours post dosing
Baseline to 12 hours post dosing

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

April 1, 2010

Primary Completion (ANTICIPATED)

May 1, 2010

Study Completion (ANTICIPATED)

May 1, 2010

Study Registration Dates

First Submitted

June 23, 2011

First Submitted That Met QC Criteria

June 23, 2011

First Posted (ESTIMATE)

June 27, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 6, 2016

Last Update Submitted That Met QC Criteria

July 5, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4040689

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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