NCT02446561

A Study of Whether 3 New Oral Formulations of a Strong Pain Killer Release the Same Amount of Drug Into the Body as the Marketed Medication

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Mundipharma Research Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To determine whether three new oral formulations of a strong pain killer release the drug into the body in a similar pattern as the already marketed reference capsule formulation with or without food

Detailed description

Comparisons will be made between three new oral formulations and an existing marketed reference capsule formulation to determine whether the release rates of the products are similar or equivalent in a fed or fasted state. Determination is by measurement of drug concentrations in the blood at serial collection time points pre-dose until 72 hours post-dose, following an administration of a single oral dose. Pharmacokinetics parameters of AUC and Cmax are the primary endpoints

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	MRXXX
DRUG	MR1XXX
DRUG	MR2XXX
DRUG	MR3XXX

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-05-18
• Last updated: 2017-08-31

Locations

1 site across 1 country: United Kingdom