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Effects of food on the pharmacokinetics of ponatinib in healthy subjects.

Narasimhan NI, Dorer DJ, Niland K, Haluska F, Sonnichsen D - J Clin Pharm Ther (2013)

Bottom Line: All limits of the 90% CIs of the estimated geometric mean ratios for Cmax and all AUC comparisons fell within the 80%-125% margins.These results indicate that consumption of a high- or low-fat meal within 30 min prior to administration of ponatinib had no effect on the single-dose pharmacokinetics of ponatinib.Food does not affect the single-dose pharmacokinetics of ponatinib.

View Article: PubMed Central - PubMed

Affiliation: ARIAD Pharmaceuticals, Inc., Cambridge, MA, USA.

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Mean ponatinib plasma concentrations vs. time for ponatinib + high- or low-fat meal, or fasting.
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fig01: Mean ponatinib plasma concentrations vs. time for ponatinib + high- or low-fat meal, or fasting.

Mentions: Maximum mean concentrations for the high-fat, low-fat and fasted regimens were reached approximately 5–6 h after oral administration of a single 45-mg ponatinib tablet and were between 51·7 and 54·5 ng/mL. Ponatinib in plasma was quantifiable through the 96-h sampling interval across all three treatment regimens. Notably, there were no differences between the respective absorption and distribution profiles for the three treatment regimens (Fig. 1). Ponatinib plasma concentrations declined in a multi-exponential manner; as expected, the elimination rate was not affected by the food regimen.


Effects of food on the pharmacokinetics of ponatinib in healthy subjects.

Narasimhan NI, Dorer DJ, Niland K, Haluska F, Sonnichsen D - J Clin Pharm Ther (2013)

Mean ponatinib plasma concentrations vs. time for ponatinib + high- or low-fat meal, or fasting.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4286001&req=5

fig01: Mean ponatinib plasma concentrations vs. time for ponatinib + high- or low-fat meal, or fasting.
Mentions: Maximum mean concentrations for the high-fat, low-fat and fasted regimens were reached approximately 5–6 h after oral administration of a single 45-mg ponatinib tablet and were between 51·7 and 54·5 ng/mL. Ponatinib in plasma was quantifiable through the 96-h sampling interval across all three treatment regimens. Notably, there were no differences between the respective absorption and distribution profiles for the three treatment regimens (Fig. 1). Ponatinib plasma concentrations declined in a multi-exponential manner; as expected, the elimination rate was not affected by the food regimen.

Bottom Line: All limits of the 90% CIs of the estimated geometric mean ratios for Cmax and all AUC comparisons fell within the 80%-125% margins.These results indicate that consumption of a high- or low-fat meal within 30 min prior to administration of ponatinib had no effect on the single-dose pharmacokinetics of ponatinib.Food does not affect the single-dose pharmacokinetics of ponatinib.

View Article: PubMed Central - PubMed

Affiliation: ARIAD Pharmaceuticals, Inc., Cambridge, MA, USA.

Show MeSH
Related in: MedlinePlus