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
A study to assess bioavailability of a single dose of MR902 and to assess the effect of food on absorption
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.
;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
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Phase 4 |