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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 (%)

Parameter

Test

Reference

Test

Reference

Cmax (ng/ml)

4616.78 ± 988.83

4917.37 ± 1068.30

21.42

21.73

tmax (hr)

0.95 ± 0.49

0.74 ± 0.42

51.53

56.08

AUC0-t (hr.ng/ml)

20062.25 ± 5642.02

20389.03 ± 5666.04

28.12

27.79

AUC0-∞ (hr.ng/ml)

21423.27 ± 5858.48

21737.66 ± 5849.22

27.35

26.91

Ke (hr-1)

0.25 ± 0.05

0.25 ± 0.05

18.69

19.09

t1/2 (hr)

2.87 ± 0.55

2.95 ± 0.78

19.08

26.38

 

Geometric Mean

Test vs. Reference

    

90% CI

 
 

Test

Reference

Ratio (%)

Lower

Upper

ISCV (%)

Cmax (ng/ml)

4515.53

4811.62

93.85

87.12

101.20

16.20

AUC0-t (hr.ng/ml)

19353.20

19754.60

97.97

94.29

101.83

8.26

AUC0-∞ (hr.ng/ml)

20716.05

21108.97

98.14

94.77

101.68

7.56

  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