A Phase 1 interventional study of Marketed paracetamol and Experimental paracetamol formulation in Healthy Subjects, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-24.
Sponsored by GlaxoSmithKline · Phase 1 and Interventional
A single dose pharmacokinetic study investigating two paracetamol formulations
GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
marketed formulation
Drug: Marketed paracetamol
Experimental formulation
Drug: Experimental paracetamol formulation
Marketed formulation
Experimental formulation
To compare bioavailability as measured by Area under the Curve in both fed and fasted states
Time frame: 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
Time frame: Visit 1 through Visit 3 (Day 13)
To assess descriptive pharmacokinetic characteristics (Tmax, T1/2, AUC, Cmax)
Time frame: Visit 1 through Visit 3 (Day 13)
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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GlaxoSmithKline