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Table 3 Pharmacokinetic properties of paracetamol from test and reference preparations (N = 27)

From: A randomized single-dose, two-period crossover bioequivalence study of two fixed-dose Paracetamol/Orphenadrine combination preparations in healthy volunteers under fasted condition

 Mean ± SD (n = 25) (Untransformed Data) CV (%)
ParameterTestReferenceTestReference
Cmax (ng/ml)4616.78 ± 988.834917.37 ± 1068.3021.4221.73
tmax (hr)0.95 ± 0.490.74 ± 0.4251.5356.08
AUC0-t (hr.ng/ml)20062.25 ± 5642.0220389.03 ± 5666.0428.1227.79
AUC0-∞ (hr.ng/ml)21423.27 ± 5858.4821737.66 ± 5849.2227.3526.91
Ke (hr-1)0.25 ± 0.050.25 ± 0.0518.6919.09
t1/2 (hr)2.87 ± 0.552.95 ± 0.7819.0826.38
 Geometric MeanTest vs. Reference
    90% CI 
 TestReferenceRatio (%)LowerUpperISCV (%)
Cmax (ng/ml)4515.534811.6293.8587.12101.2016.20
AUC0-t (hr.ng/ml)19353.2019754.6097.9794.29101.838.26
AUC0-∞ (hr.ng/ml)20716.0521108.9798.1494.77101.687.56
  1. SD Standard deviation, CV Coefficient variation, Cmax maximum observed plasma concentration, tmax, time to maximum plasma concentration, AUC0-t, area under the concentration-time curve from the time zero to the time point of last quantifiable plasma concentration, AUC0-∞, Area under the concentration-time curve from time zero and extrapolated to infinity, Ke, elimination rate constant, t1/2, elimination half-life, CI Confidence interval, ISCV Intrasubject coefficient variation