Last updated: 11/04/2018 04:20:43
Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption from a new formulation of Paracetamol Compared with Panadol® Extend
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A single dose PK study investigating the extent of paracetamol absorption from two different sustained released paracetamol formulations
Trial description: This study will evaluate the pharmacokinetic profiles of experimental formulations of paracetamol.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Bioavailability as measured by Area Under the Curve (AUC) in both fasted and fed state
Timeframe: baseline to 12 hours
Effect of food on the extent and rate of paracetamol absorption as measured by AUC and Cmax
Timeframe: baseline to 12 hours
Secondary outcomes:
To assess descriptive pharmaokinetic characteristics (Tmax, T1/2, Cmax, AUC)
Timeframe: baseline to 12 hours
Interventions:
Drug: Marketed paracetamol
Drug: Experimental paracetamol formulation
Enrollment:
28
Observational study model:
Not applicable
Primary completion date:
2010-05-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy Subjects
Product
paracetamol
Collaborators
Not applicable
Study date(s)
December 2009 to January 2010
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Good health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination
- Current (within 14 days of screening) or regular use of any prescription, over the counter (OTC) drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism, excluding prescription birth control, if applicable.
Inclusion and exclusion criteria
Inclusion criteria:
- Good health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination
Exclusion criteria:
- Current (within 14 days of screening) or regular use of any prescription, over the counter (OTC) drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism, 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
2010-05-01
Actual study completion date
2010-05-01
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