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A Study to Compare Two Paracetamol Tablets

This study has been withdrawn prior to enrollment.
(Study was cancelled prior to enrolling any subjects.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01381640
First Posted: June 27, 2011
Last Update Posted: July 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
This is a single dose pharmacoscintigraphic study investigating the differences in paracetamol absorption between two formulations.

Condition Intervention Phase
Healthy Subjects Drug: Marketed paracetamol Drug: Experimental paracetamol formulation Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Single Dose Pharmacoscintigraphic Study Investigating the Differences in Gastrointestinal Behavior and Paracetamol Absorption Between Sustained Release Formula and Standard Release Formula

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To assess the gastrointestinal transit by qualitative scintigraphic analysis [ Time Frame: Baseline to 12 hours post dosing ]

Enrollment: 0
Study Start Date: April 2010
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Marketed paracetamol
Marketed formulation
Drug: Marketed paracetamol
marketed formulation
Experimental: Experimental paracetamol formulation
Experimental formulation
Drug: Experimental paracetamol formulation
Experimental formulation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01381640


Locations
United Kingdom
BIO-IMAGES Research Ltd.
Glasgow, Scotland, United Kingdom, G63 0BX
Bio-Images
Glasgow, Scotland, United Kingdom, G63 0BX
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01381640     History of Changes
Other Study ID Numbers: A4040689
First Submitted: June 23, 2011
First Posted: June 27, 2011
Last Update Posted: July 6, 2016
Last Verified: July 2016

Keywords provided by GlaxoSmithKline:
paracetamol
healthy volunteer
pharmacoscintography

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics