Last updated: 11/04/2018 04:20:58
A study to compare to the pharmacokinetic profile of two paracetamol formulations
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A repeat dose PK study investigating the extent of paracetamol absorption from two sustained release paracetamol formulations
Trial description: A repeat dose pharmacokinetic study investigating two paracetamol formulations
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Bioequivalence as measured by Area Under the Curve (AUC)
Timeframe: last 24 hours of dosing
Secondary outcomes:
Time duration at or above minimal therapeutic plasma paracetamol concentration
Timeframe: last 24 hours of dosing
To assess pharmacokinetic parameters (Cmax, AUC, Tmax and Kel)
Timeframe: last 24 hours of dosing
Adverse events
Timeframe: Baseline to 72 hours post dosing
Interventions:
Drug: Experimental paracetamol formulation
Drug: Marketed paracetamol
Drug: Higher dose marketed paracetamol
Enrollment:
28
Observational study model:
Not applicable
Primary completion date:
2009-31-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy Subjects
Product
Not applicable
Collaborators
Not applicable
Study date(s)
November 2009 to December 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
- Subject does not agree to refrain from alcohol consumption for the 10-day period prior to visit 2 and throughout the study.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
Inclusion and exclusion criteria
Inclusion criteria:
- Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
Exclusion criteria:
- Subject does not agree to refrain from alcohol consumption for the 10-day period prior to visit 2 and throughout the study.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Current (within 14 days of screening) or regular use of any prescription, over-the-counter drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing (e.g. barbiturates, theophylline, cimetidine, or erythromycin), excluding prescription birth control, if applicable.
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
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