Last updated: 11/04/2018 04:23:09
A study to investigate a new paracetamol formulation
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A single dose pharmacoscintigraphic study investigating the differences in gastrointestinal behaviour and paracetamol absorption between two paracetamol formulations
Trial description: This study has been designed to compare a new paracetamol formulation with a marketed formulation.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
To determine tablet disintegration time
Timeframe: baseline to 30 minutes post dosing
Secondary outcomes:
Time to completion of tablet disintegration
Timeframe: baseline to 10 hours post dosing
To compare pharmacokinetic profiles of two paracetamol formulations
Timeframe: Up to 10 hours post dose
Time to assess detectable levels of drug absorption
Timeframe: baseline to 10 hours post dosing
Time to reach the minimal therapeutic level of paracetamol
Timeframe: baseline to 10 hours post dosing
To assess the frequency of adverse events
Timeframe: baseline to 10 hours post dosing
Interventions:
Drug: Marketed paracetamol
Drug: Experimental paracetamol formulation
Enrollment:
35
Observational study model:
Not applicable
Primary completion date:
2010-01-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy Subjects, Analgesia
Product
paracetamol
Collaborators
Not applicable
Study date(s)
March 2010 to May 2010
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 65 Year
Accepts healthy volunteers
yes
- Inclusion Criteria:
- Healthy male subjects who are in good general health and who have not exceeded the limits of total radiation exposure allowed in any 12 month period.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria:
- Healthy male subjects who are in good general health and who have not exceeded the limits of total radiation exposure allowed in any 12 month period.
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2010-01-05
Actual study completion date
2010-01-05
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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