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Table 2 Descriptive statistics of formulation means for montelukast (n = 40)

From: Bioequivalence of two formulations of montelukast sodium 4 mg oral granules in healthy adults

Parameters (Units) Mean ± SD (un-transformed data)
Sandoz montelukast 4 mg oral granules Singulair® mini 4 mg oral granules
Tmax (h)* 2.75 2.75
Cmax (ng/ml) 178.04 ± 41.58 196.04 ± 53.25
AUC0–t (ng.h/ml) 1083.00 ± 293.88 1112.84 ± 309.13
AUC0-∞ (ng.h/ml) 1134.70 ± 305.17 1170.45 ± 321.90
λz (1/h) 0.17 ± 0.038 0.18 ± 0.042
t½ (h) 4.36 ± 1.00 4.04 ± 1.06
Residual area 4.71 ± 1.86 5.13 ± 2.32
(AUC_% Extrap_Obs (%))
  1. *median value.
  2. Tmax: time of the maximum measured plasma concentration.
  3. Cmax: maximum measured plasma concentration.
  4. AUC0–t: the area under the plasma concentration versus time curve from time zero to the last measurable concentration.
  5. AUC0–∞: the area under the plasma concentration versus time curve from time zero to infinity.
  6. AUC_% Extrap_Obs (%): % of the AUC that has been derived after extrapolation.
  7. λz: first order rate constant associated with the terminal (log-linear) portion of the curve.
  8. t½: the elimination or terminal half-life.