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Table 3 90% confidence intervals of LnCmax, LnAUC0–t, and LnAUC0– from the test formulations to the reference formulation

From: Bioequivalence study of different brands of vildagliptin in healthy human subjects

Pharmacokinetic parameter

Geo mean ratio

90% confidence interval (lower limit-upper limit)

Test/reference

T1/R

T2/R

Test 1

Test 2

Bioequivalence range

LnCmax

1.0014

1.0003

1.0002–1.0026

0.9992–1.0013

0.80–1.25

LnAUC0–t

0.9992

0.9988

0.9971–1.0013

0.9969–1.0008

0.80–1.25

LnAUC0–

0.9994

0.9985

0.9973–1.0016

0.9961–1.0010

0.80–1.25

  1. Bioequivalence interpretation requires the 90% confidence intervals to be within the acceptance criteria of 0.8–1.25