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Table 2 Pharmacokinetic properties of orphenadrine from test and reference preparations (n = 25)

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)32.75 ± 8.0530.81 ± 7.5724.6024.58
tmax (hr)3.39 ± 1.333.28 ± 0.9139.2427.78
AUC0-t (hr.ng/ml)572.74 ± 231.43541.10 ± 233.4140.4143.14
AUC0-∞ (hr.ng/ml)671.67 ± 262.47655.28 ± 273.7739.0841.78
Ke (hr-1)0.04 ± 0.020.04 ± 0.0137.9828.15
t1/2 (hr)19.05 ± 6.4220.69 ± 6.9533.7133.61
 Geometric MeanTest vs. Reference
    90% CI 
 TestReferenceRatio (%)LowerUpperISCV (%)
Cmax (ng/ml)31.7630.01105.83100.11112.5012.00
AUC0-t (hr.ng/ml)527.38494.81106.63100.92111.2710.03
AUC0-∞ (hr.ng/ml)623.74607.28102.7196.94108.0811.17
  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