P for Exceeding the Limits of Acceptance for Bioavailability
Compound
Parameter
Ratio Test/
Reference,%
90% CI
<80%
>125%
Power
clopidogrel
Cmax
94.4
90.26–113.91
0.001
<0.001
0.99
AUC0–t
100.4
91.82–103.27
<0.001
<0.001
0.99
AUC0–∞
102.0
93.67–106.89
<0.001
<0.001
0.99
SR26334
Cmax
90.1
85.23–112.97
0.002
<0.001
0.99
AUC0–t
95.6
93.11–103.67
<0.001
<0.001
0.99
AUC0–∞
95.8
88.67–101.53
<0.001
<0.001
0.99
Table 2: Comparison of 90% Cls of natural log (ln)-transformed parameters for clopidogrel and SR26334 following administration of 2 formulations (Test/Reference) of
clopidogrel tablets in healthy Chinese male volunteers.
