ArticlePharmaceutical research2015
Model-based evaluation of the impact of formulation and food intake on the complex oral absorption of mavoglurant in healthy subjects.
Article in Pharmaceutical research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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Who cites it
12 citing papers in PubMed.
- Effect of Activated Charcoal on Rivaroxaban Complex Absorption.Clinical pharmacokinetics · 2017Trial
- Article
- Is the One-Compartment Model with First Order Absorption a Useful Approximation?Pharmaceutical research · 2023Article
- The Finite Absorption Time (FAT) concept en route to PBPK modeling and pharmacometrics.Journal of pharmacokinetics and pharmacodynamics · 2023Article
- Analysis of Complex Absorption After Multiple Dosing: Application to the Interaction Between the P-glycoprotein Substrate Talinolol and Rifampicin.Pharmaceutical research · 2022Article
- Non-Linear Pharmacokinetics of Oral Roscovitine (Seliciclib) in Cystic Fibrosis Patients Chronically Infected withPharmaceutics · 2020Article
- A distributed delay approach for modeling delayed outcomes in pharmacokinetics and pharmacodynamics studies.Journal of pharmacokinetics and pharmacodynamics · 2018Article
- Biopharmaceutical Evaluation and CMC Aspects of Oral Modified Release Formulations.The AAPS journal · 2017Article
- Empirical models for fitting of oral concentration time curves with and without an intravenous reference.Journal of pharmacokinetics and pharmacodynamics · 2017Article
- Reduction of a Whole-Body Physiologically Based Pharmacokinetic Model to Stabilise the Bayesian Analysis of Clinical Data.The AAPS journal · 2016Article
- Application of a Bayesian approach to physiological modelling of mavoglurant population pharmacokinetics.Journal of pharmacokinetics and pharmacodynamics · 2015Article
- Incorporation of stochastic variability in mechanistic population pharmacokinetic models: handling the physiological constraints using normal transformations.Journal of pharmacokinetics and pharmacodynamics · 2015Article
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
purposeTo compare the pharmacokinetics of intravenous (IV), oral immediate-release (IR) and oral modified-release (MR) formulations of mavoglurant in healthy subjects, and to assess the food effect on the MR formulation's input characteristics.
methodsPlasma concentration-time data from two clinical studies in healthy volunteers were pooled and analysed using NONMEM®. Drug entry into the systemic circulation was modelled using a sum of inverse Gaussian (IG) functions as an input rate function, which was estimated specifically for each formulation and food state.
resultsMavoglurant pharmacokinetics was best described by a two-compartment model with a sum of either two or three IG functions as input function. The mean absolute bioavailability from the MR formulation (0.387) was less than from the IR formulation (0.436). The MR formulation pharmacokinetics were significantly impacted by food: bioavailability was higher (0.508) and the input process was shorter (complete in approximately 36 versus 12 h for the fasted and fed states, respectively).
conclusionsModelling and simulation of mavoglurant pharmacokinetics indicate that the MR formulation might provide a slightly lower steady-state concentration range with lower peaks (possibly better drug tolerance) than the IR formulation, and that the MR formulation's input properties strongly depend on the food conditions at drug administration.
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