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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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01381640
First received: June 23, 2011
Last updated: January 24, 2013
Last verified: March 2012
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the gastrointestinal transit by qualitative scintigraphic analysis [ Time Frame: Baseline to 12 hours post dosing ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01381640     History of Changes
Other Study ID Numbers: A4040689
Study First Received: June 23, 2011
Last Updated: January 24, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
paracetamol
healthy volunteer
pharmacoscintography

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

ClinicalTrials.gov processed this record on May 16, 2013