Last updated: 11/04/2018 04:22:59
A study to compare two paracetamol formulations.
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A pharmacokinetic study investigating the rate and extent of absorption of paracetamol and an adjuvant from two different paracetamol formulations.
Trial description: A pharmacokinetic study investigating the rate and extent of absorption of paracetamol and an adjuvant from two different paracetamol formulations.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Bioequivalence as measured by AUC and Cmax in fasted and semi-fed states
Timeframe: baseline to 10 hours post dose
Secondary outcomes:
Speed of absorption in fasted and semi-fed states
Timeframe: baseline to 10 hours post dose
Interventions:
Drug: Marketed paracetamol
Drug: Experimental paracetamol formulation
Enrollment:
30
Observational study model:
Not applicable
Primary completion date:
2009-31-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pain
Product
paracetamol
Collaborators
Not applicable
Study date(s)
December 2009 to December 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Inclusion Criteria:
- Healthy male or female volunteers aged 18-55 years with a body mass index ranging from 19-28 kilograms per square meter who have given informed consent
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria:
- Healthy male or female volunteers aged 18-55 years with a body mass index ranging from 19-28 kilograms per square meter who have given informed consent
Trial location(s)
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
2009-31-12
Actual study completion date
2009-31-12
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website