Study to Assess Pharmacokinetic (PK), Bioavailability & Food Effect of MR902 Compared With Immediate Release (IR) Morphine Sulphate Oral Solution

Opioid Substitution Treatment Clinical Trial

Official title: 2-cohort, 3-part, Open-label, Randomised, Single Dose, Crossover Study in Healthy Subjects to Compare PK & Bioavailability of a Single Dose, in Fed and Fasted State, of MR902 Prolonged Release (PR) Tablets With Immediate Release (IR) Morphine Sulfate Oral Solution

Status Completed

Clinical Trial Summary

A study to assess bioavailability of a single dose of MR902 and to assess the effect of food on absorption

Clinical Trial Description

Volunteers will receive a single dose of the investigational drug on 2 occasions and a reference drug on 1 occasion. Volunteers will be randomised to one of two groups, each group receiving a different dose strength of MR902 in fed and fasted state.

The study involves a screening visit 21 days before first dosing and 3 overnight stays in 3 study periods, and a post-study medical visit.

Volunteers will receive naltrexone to reduce anticipated opioid side effects. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid Substitution Treatment

• NCT number: NCT02773316
• Study type: Interventional
• Source: Mundipharma Research Limited
• Status: Completed
• Phase: Phase 1
• Start date: September 2015
• Completion date: November 2015