We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

A Study to Compare Two Paracetamol Tablets

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.
ClinicalTrials.gov Identifier: NCT01381640
Recruitment Status : Withdrawn (Study was cancelled prior to enrolling any subjects.)
First Posted : June 27, 2011
Last Update Posted : July 6, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a single dose pharmacoscintigraphic study investigating the differences in paracetamol absorption between two formulations.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Marketed paracetamol Drug: Experimental paracetamol formulation Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : April 2010
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : May 2010
Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. To assess the gastrointestinal transit by qualitative scintigraphic analysis [ Time Frame: Baseline to 12 hours post dosing ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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

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

Keywords provided by GlaxoSmithKline:
healthy volunteer

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