Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol® Extend
A Single Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Different Sustained Released Paracetamol Formulations
1 other identifier
interventional
28
1 country
1
Brief Summary
This study will evaluate the pharmacokinetic profiles of experimental formulations of paracetamol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 23, 2012
CompletedFirst Posted
Study publicly available on registry
February 29, 2012
CompletedNovember 24, 2014
June 1, 2014
Same day
February 23, 2012
November 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Bioavailability as measured by Area Under the Curve (AUC) in both fasted and fed state
baseline to 12 hours
Effect of food on the extent and rate of paracetamol absorption as measured by AUC and Cmax
baseline to 12 hours
Secondary Outcomes (1)
To assess descriptive pharmaokinetic characteristics (Tmax, T1/2, Cmax, AUC)
baseline to 12 hours
Study Arms (2)
Experimental paracetamol formulation
EXPERIMENTALExperimental formulation
Marketed paracetamol
ACTIVE COMPARATORMarketed formulation
Interventions
Experimental formulation
Eligibility Criteria
You may qualify if:
- Good health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
MDS Pharma Services NEBRASKA
Lincoln, Nebraska, 68501, United States
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2012
First Posted
February 29, 2012
Study Start
December 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
November 24, 2014
Record last verified: 2014-06