A Phase 1 interventional study of Paracetamol in Fever, Headache Disorders and Pain, sponsored by GlaxoSmithKline. Completed. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-14.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
A pharmacokinetic study in healthy volunteers comparing two formulations of paracetamol fast release in fasted state.
605 studies on the registry are indexed under Fever; 98 are open to participants now.
This study's enrollment of 30 is below the median of 100 across 386 interventional studies indexed under Fever.
Browse Fever studies →GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.
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Exclusion Criteria:
Experimental paracetamol tablet (500 milligrams \[mg\]) administered with 240 milliliters (mL) of water.
Drug: Paracetamol
Standard paracetamol tablet (500 mg) administered with 240 mL of water.
Drug: Paracetamol
500 mg immediate release paracetamol formulations
AUC (0-inf)
Area under the plasma concentration time curve from zero and extrapolated to infinite time.
Time frame: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.
Cmax
Maximum plasma concentration of paracetamol.
Time frame: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.
AUC (0-t)
Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample.
Time frame: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.
Tmax
Time taken to reach maximum plasma concentration of paracetamol.
Time frame: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.
No study locations are listed for this record.
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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