Last updated: 11/04/2018 04:22:01
A study to compare two paracetamol tablets
GSK study ID
A4040689
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Withdrawn
Withdrawn
Trial overview
Official title: A single dose pharmacoscintigraphic study investigating the differences in gastrointestinal behavior and paracetamol absorption between sustained release formula and standard release formula
Trial description: This is a single dose pharmacoscintigraphic study investigating the differences in paracetamol absorption between two formulations.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Time of onset and completion of disintegration based on release of radiolabeled markers in a fed condition
Timeframe: Baseline to 12 hours post dosing
Secondary outcomes:
To assess the gastrointestinal transit by qualitative scintigraphic analysis
Timeframe: Baseline to 12 hours post dosing
Interventions:
Drug: Marketed paracetamol
Drug: Experimental paracetamol formulation
Enrollment:
0
Observational study model:
Not applicable
Primary completion date:
2010-30-04
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy Subjects
Product
paracetamol
Collaborators
Not applicable
Study date(s)
April 2010 to April 2010
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Inclusion Criteria:
- Healthy male subjects who are in good general health
Inclusion and exclusion criteria
Inclusion 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
Trial location(s)
Location
BIO-IMAGES Research Ltd.
Glasgow, Scotland, United Kingdom, G63 0BX
Status
Will Be Recruiting
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Withdrawn
Actual primary completion date
2010-30-04
Actual study completion date
2010-30-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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