NCT02773316

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Mundipharma Research Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Opioid Substitution Treatment

Interventions

Type	Name	Description
DRUG	MR902
DRUG	IR morphine sulphate

Timeline

• Start date: 2015-09-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2016-05-16
• Last updated: 2016-05-16