Study Stopped
Study was cancelled prior to enrolling any subjects.
A Study to Compare Two Paracetamol Tablets
A Single Dose Pharmacoscintigraphic Study Investigating the Differences in Gastrointestinal Behavior and Paracetamol Absorption Between Sustained Release Formula and Standard Release Formula
1 other identifier
interventional
N/A
1 country
2
Brief Summary
This is a single dose pharmacoscintigraphic study investigating the differences in paracetamol absorption between two formulations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2010
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 23, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedJuly 6, 2016
July 1, 2016
1 month
June 23, 2011
July 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time of onset and completion of disintegration based on release of radiolabeled markers in a fed condition
Baseline to 12 hours post dosing
Secondary Outcomes (1)
To assess the gastrointestinal transit by qualitative scintigraphic analysis
Baseline to 12 hours post dosing
Study Arms (2)
Marketed paracetamol
ACTIVE COMPARATORMarketed formulation
Experimental paracetamol formulation
EXPERIMENTALExperimental formulation
Interventions
Experimental formulation
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (2)
BIO-IMAGES Research Ltd.
Glasgow, Scotland, G63 0BX, United Kingdom
Bio-Images
Glasgow, Scotland, G63 0BX, United Kingdom
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2011
First Posted
June 27, 2011
Study Start
April 1, 2010
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
July 6, 2016
Record last verified: 2016-07