Term

Time (hours) Fasted State

Time (hours) Semi-Fed State

New

Current

Diff.

P-value

New

Current

Diff.

P-value

T4 1

0.17

0.37

-0.20

<.0001

0.36

0.73

-0.36

<.0001

Tmax 2

0.50

0.99

-0.26

<.0001

1.00

1.25

-0.24

=0.0136


1 Time for T4 is mean time to reach plasma paracetamol concentration equal or greater than 4μg/ml based on Least Square means from Proc Mixed of SAS and P-value is associated with the t-test.
2 Time for Tmax is median time to reach maximum plasma paracetamol concentration and P-value is associated with Wilcoxon Signed Rank test for median of differences (New – Current) across all subjects.
Table 3: Time to reach plasma paracetamol concentration at therapeutic level (4ug/ml) and Tmax for new and current Panadol Extra in fasted and semi-fed state.
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