A PK/PD study comparing twice-daily to once-daily dosing regimens of ertugliflozin in healthy subjects
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ABSTRACT:

Objective

Ertugliflozin is approved in the US and European Union as a stand-alone product for adults with type 2 diabetes mellitus as once daily (QD) dosing. The approved fixed-dose combination (FDC) of ertugliflozin and immediate-release metformin is dosed twice daily (BID). This study assessed steady-state pharmacokinetics (PK; area under the concentration-time curve over 24 hours (AUC₂₄)) and pharmacodynamics (PD; urinary glucose excretion over 24 hours (UGE₂₄)) for ertugliflozin 5 and 15 mg total daily doses administered BID or QD.

Materials and methods

In this open-label, two-cohort, randomized, multiple-dose, crossover study, healthy subjects received ertugliflozin 2.5 mg BID and 5 mg QD (n = 28) or ertugliflozin 7.5 mg BID and 15 mg QD (n = 22) f

SUBMITTER: Dawra VK 

PROVIDER: S-EPMC6528385 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature