Parameter

Geometric Mean Ratio, % (90% CI)

Probability of Exceeding Limits of Acceptance

Power

P<80%

P<125%

Cmax

102.71 (90.13-117.04)

<0.01

0.01

0.88

AUC0–t

102.29 (92.45-113.18)

<0.01

<0.01

0.98

AUC0–∞

101.10 (94.50-108.16)

<0.01

<0.01

1.00


AUC0–t =AUC from time 0 (baseline) to the last measurable concentration
AUC0–∞= AUC from baseline extrapolated to infinity
*Values were calculated from the natural logarithm-transformed data
†Trademark: Prazolan® (Laboratorios Liomont, S. A. de C. V., Mexico City, Mexico)
‡Trademark: Pantozol® (NYCOMED, S. A. de C. V., Mexico City, Mexico)
Table 2: Geometric mean ratios (90% CI) of pharmacokinetic parameters,* the probabilities of exceeding the predetermined limits of bioequivalence (80%- 125%), and the power test results from a single-dose administration of a test† and a reference‡ formulation of oral pantoprazole 40 mg in healthy Mexican adult subjects.
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