Application of pharmacometric approaches to evaluate effect of weight and renal function on pharmacokinetics of alogliptin.

ABSTRACT:

Aims

The aims of the study were to characterize the pharmacokinetics (PK) of alogliptin in healthy and type 2 diabetes mellitus (T2DM) subjects using a population PK approach and to assess the influence of various covariates on alogliptin exposure.

Methods

Plasma concentration data collected from two phase 1 studies and one phase 3 study following administration of alogliptin (12.5-400 mg) were used for the PK model development. One- and two-compartment models were evaluated as base structural PK models. The impact of selected covariates was assessed using stepwise forward selection and backward elimination procedures. The predictability and robustness of the final model was evaluated using visual predictive check and bootstrap analyses. The final model was used to perform s

SUBMITTER: Naik H 

PROVIDER: S-EPMC4799927 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature