Last updated: 11/04/2018 04:18:57
A pharmacokinetic study of an experimental paracetamol formulation
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A pivotal pharmacokinetic study investigating the extent of absorptions of paracetamol and caffeine for two different paracetomol formulations containing caffeine
Trial description: This PK study is designed to show bioequivalence between the study treatments.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
PK variables (AUC 0-10hrs, AUC 0-inf, and Cmax) to determine bioequivalence
Timeframe: 10 hours
Secondary outcomes:
PK variables to compare speed of absorption (AUC 0-30min, AUC 0-60min, Tmax)
Timeframe: 10 hours
Interventions:
Drug: Experimental paracetamol
Drug: Paracetamol marketed formulation
Enrollment:
30
Observational study model:
Not applicable
Primary completion date:
2009-31-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Headache, Tension-Type
Product
paracetamol
Collaborators
Not applicable
Study date(s)
July 2009 to August 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Healthy volunteer
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy volunteer
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
2009-31-08
Actual study completion date
2009-31-08
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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