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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

NCT02089581 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2015-09-28

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Mundipharma Research Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-05-31
Completion
2015-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02089581 on ClinicalTrials.gov