Parameter

Geometric Mean
Ratio (%)

90% CI

Probability of Exceeding Limits of Acceptance
(lower; upper)

Intra-subject
%CV

Telmisartan 40 mg

 

 

 

 

 

Cmax

92.32

81.23; 104.94

<0.01

<0.01

29.7

AUC0-t,

103.39

92.61; 115.41

<0.01

<0.01

25.4

AUC0-∞

102.79

91.83; 115.05

<0.01

<0.01

24.6

 

 

 

 

 

 

Telmisartan 80 mg

 

 

 

 

 

Cmax

102.53

86.84; 121.07

<0.01

<0.01

39.1

AUC0-t,

99.96

90.51; 110.38

<0.01

<0.01

22.8

AUC0-∞

100.25

90.58; 110.96

<0.01

<0.01

22.9

AUC0-t = AUC from time 0 (baseline) to the last measurable concentration
AUC0-∞ = AUC from baseline extrapolated to infinity
*The limits of acceptance of Cmax (for both studies) are from 75% to 133%, where as the limits of acceptance for both AUC0-t and AUC0-∞  are from 80% to 125%.

Table 2: Geometric mean ratios, 90% CIs, the probabilities of exceeding the limits of acceptance and the intra-subject %CV of the pharmacokinetic parameters determined for telmisartan after a single-dose administration of telmisartan (40 mg or 80 mg) in healthy male Mexican subjects.