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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.
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Clinical and Translational Allergy

ISSN: 2045-7022

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