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This study has been withdrawn prior to enrollment.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: June 20, 2013
Last verified: January 2013
  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: 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:


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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01381640

Locations
United Kingdom
Bio-Images
Glasgow, Scotland, United Kingdom, G63 0BX
BIO-IMAGES Research Ltd.
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: June 20, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
paracetamol
healthy volunteer
pharmacoscintography

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

ClinicalTrials.gov processed this record on October 21, 2014