Last updated: 11/04/2018 04:20:51
Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption from a new formulation of Paracetamol Compared with Panadol®
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 sustained release paracetamol formulations
Trial description: A single dose pharmacokinetic study investigating two paracetamol formulations
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
To compare bioavailability as measured by Area under the Curve in both fed and fasted states
Timeframe: Visit 1 through Visit 3 (Day 13)
To assess the effect of food on extent and rate of paracetamol absorption as measured by Area Under the Curve and Cmax
Timeframe: Visit 1 through Visit 3 (Day 13)
Secondary outcomes:
To assess descriptive pharmacokinetic characteristics (Tmax, T1/2, AUC, Cmax)
Timeframe: Visit 1 through Visit 3 (Day 13)
Interventions:
Drug: Marketed paracetamol
Drug: Experimental paracetamol formulation
Enrollment:
28
Observational study model:
Not applicable
Primary completion date:
2010-08-01
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 general heatlh 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 remainder of 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 heatlh 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 remainder of 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.
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
2010-08-01
Actual study completion date
2010-08-01
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
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