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A Study to Assess How the Body Processes a Strong Painkiller When it is Given Alongside a Drug That Counteracts the Side Effects of Strong Painkillers in a Fasted and Fed State.

Pain Clinical Trial

Official title:
A 4-part, Single-dose, Open-label, Randomised, Crossover, Exploratory Study in Healthy Subjects to Assess the Influence of an Opioid Antagonist on How the Body Processes a Strong Painkiller, When Co-administered in a Fasted and Fed State.

Clinical Trial Summary

To assess whether an opioid antagonist has any impact on the release of a strong painkiller in the blood when it is given to healthy volunteers when they have eaten and also when they have fasted.

Clinical Trial Description

This is an exploratory study to assess the influence of an opioid antagonist on the pharmacokinetics of a strong painkiller when co-administered in a fasted and fed state.

Determination is by measurement of drug concentrations in the blood at serial collection time points pre-dose until 32 hours post-dose, following an administration of a single oral dose. Pharmacokinetics parameters of AUC and Cmax are the primary endpoints. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02133820
Study type Interventional
Source Mundipharma Research Limited
Contact
Status Completed
Phase Phase 1
Start date April 2014
Completion date June 2014
View Details
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