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Aim
To determine the absolute oral bioavailability (Fpo) of saxagliptin and dapagliflozin using simultaneous intravenous 14C‐microdose/therapeutic oral dosing (IVmicro+POtherap).
MethodsThe Fpo values of saxagliptin and dapagliflozin were determined in healthy subjects (n=7 and 8, respectively) following the concomitant administration of single IVmicro with unlabelled POtherap doses. Accelerator mass spectrometry and liquid chromatography‐tandem mass spectrometry were used to quantify the labelled and unlabelled drug, respectively.
ResultsThe geometric mean point estimates [90% CI] Fpo values for saxagliptin and dapagliflozin were 50% [48‐53%] and 78% [73‐83], respectively. The IVmicro had similar pharmacokinetics to POtherap.
ConclusionsSimultaneous IVmicro+POtherap dosing is a valuable tool to assess human absolute bioavailability.
| Authors: | David W Boulton, Sreeneeranj Kasichayanula, Chi Fung (Anther) Keung, Mark E Arnold, Lisa J Christopher, Xiaohui (Sophia) Xu, Frank LaCreta | |
| Journal: | British Journal of Clinical Pharmacology | |
| Year: | 2012 | |
| Pages: | n/a | |
| DOI: | 10.1111/j.1365-2125.2012.04391.x | |
| Publication date: | 24-07-2012 |
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