A repeat dose pharmacokinetic study investigating two paracetamol formulations
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
28
experimental
Marketed paracetamol
Higher dose marketed paracetamol
MDS Pharma Services NEBRASKA
Lincoln, Nebraska, United States
Bioequivalence as measured by Area Under the Curve (AUC)
Time frame: last 24 hours of dosing
Time duration at or above minimal therapeutic plasma paracetamol concentration
Time frame: last 24 hours of dosing
To assess pharmacokinetic parameters (Cmax, AUC, Tmax and Kel)
Time frame: last 24 hours of dosing
Adverse events
Time frame: Baseline to 72 hours post dosing
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