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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 (%)

Parameter

Test

Reference

Test

Reference

Cmax (ng/ml)

32.75 ± 8.05

30.81 ± 7.57

24.60

24.58

tmax (hr)

3.39 ± 1.33

3.28 ± 0.91

39.24

27.78

AUC0-t (hr.ng/ml)

572.74 ± 231.43

541.10 ± 233.41

40.41

43.14

AUC0-∞ (hr.ng/ml)

671.67 ± 262.47

655.28 ± 273.77

39.08

41.78

Ke (hr-1)

0.04 ± 0.02

0.04 ± 0.01

37.98

28.15

t1/2 (hr)

19.05 ± 6.42

20.69 ± 6.95

33.71

33.61

 

Geometric Mean

Test vs. Reference

    

90% CI

 
 

Test

Reference

Ratio (%)

Lower

Upper

ISCV (%)

Cmax (ng/ml)

31.76

30.01

105.83

100.11

112.50

12.00

AUC0-t (hr.ng/ml)

527.38

494.81

106.63

100.92

111.27

10.03

AUC0-∞ (hr.ng/ml)

623.74

607.28

102.71

96.94

108.08

11.17

  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
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BMC Pharmacology and Toxicology

ISSN: 2050-6511

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