NCT02089581

A Study of Whether 2 New Oral Formulations of a Strong Pain Killer Release the Same Amount of Drug Into the Body as the Marketed Medication

An Open-label, Randomised, Crossover, Single-dose, Study in Healthy Subjects to Compare the Pharmacokinetics of Two Formulations of a Strong Pain Killer With a Marketed Reference Product in a Fasted or Fed State

• 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 two 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 two 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 32 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	Active comparator MR2XXX	comparison of two new oral formulations with existing formulation
DRUG	MRXXX	MRXXX
DRUG	MR1XXX
DRUG	MRXXX and MR1XXX	MRXXX and MR1XXX in fed and fasted state

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-05-01
• Completion: 2015-07-01
• First posted: 2014-03-18
• Last updated: 2015-09-28

Locations

2 sites across 1 country: United Kingdom