A quantitative enterohepatic circulation model: development and evaluation with tesofensine and meloxicam

What Was Tested

Researchers studied Tesofensine (non-peptide) in this randomized controlled trial publication.

The aim of this analysis was to accomplish a model that is able to describe typical plasma concentration-time profiles of compounds undergoing EHC using data from intravenous studies of tesofensine and meloxicam.

Who Took Part

PubMed indexes the participants as young adults, adults and middle-aged adults, men only.

Two studies were investigated retrospectively for model development and model evaluation.

How the Study Was Run

The design is described as randomized, double-blind, placebo-controlled and crossover.

The participants were allocated by chance, so the Tesofensine (non-peptide) group and the comparison group should start out alike.

Blinding on both sides kept the participants and researchers unaware of who received Tesofensine (non-peptide).

The comparison arm used a placebo, so changes seen with Tesofensine (non-peptide) could be set against what happens without it.

Each person switched between Tesofensine (non-peptide) and the comparison at some point, usually with a gap in between.

The EHC model was developed based on data from the tesofensine study, where EHC is suspected.

Model evaluation was performed with data from the meloxicam trial.

Modelling and simulation analyses were performed using the software programs NONMEM, SAS and Berkeley Madonna.

What Was Measured

The subject headings attached to it are Bridged Bicyclo Compounds, Heterocyclic, Enterohepatic Circulation, Evaluation Studies as Topic, Half-Life, Meloxicam, Models, Biological and Thiazines.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Tesofensine (non-peptide).

Results are reported in around 7 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2009 (Clinical pharmacokinetics), a journal based in Switzerland.

More context: the Tesofensine (non-peptide) compound page, all human trials.