Trials Sponsors Conditions Drugs Pricing

Conditions

Opioid Substitution Treatment

Outcome Measures

Primary Outcomes (2)

Measure the observed maximum plasma or serum concentration after administration (Cmax)
PK plasma parameters
Pre-dose to 24 hours post-dose
Measure the area under the concentration-time curve from zero up to a definite time t after administration (AUCt)
PK Plasma Parameters
Pre-dose to 24 hours post-dose

Secondary Outcomes (9)

measurement of Pharmacokinetic parameter Area under the curve to infinity after administration (AUCINF)
Pre-dose to 24 hours post-dose
measurement of Pharmacokinetic parameter time to maximum concentration after administration (tmax)
Pre-dose to 24 hours post-dose
measurement of Pharmacokinetic parameter of elimination rate after administration (LambdaZ,)
Pre-dose to 24 hours post-dose
Measurement of Pharmacokinetic parameter elimination of half life after administration ( t1/2Z)
Pre-dose to 24 hours post-dose
Measurement of heart rate
Pre-dose to 24 hours post-dose
+4 more secondary outcomes

Study Arms (3)

MR902 50/0.5 mg

EXPERIMENTAL

MR902 50/0.5 mg PR tablets, single dose oral

Drug: MR902

MR902 200/2 mg

EXPERIMENTAL

MR902 200/2 mg PR tablets, single dose oral

Drug: MR902

IR morphine sulphate 10 mg/5mL solution

ACTIVE COMPARATOR

IR morphine sulphate 10 mg/5mL solution, single dose oral

Drug: IR morphine sulphate

Interventions

MR902Drug

MR902 200/2 mgMR902 50/0.5 mg

IR morphine sulphateDrug

Also known as: IR morphine sulphate 10 mg/mL solution

IR morphine sulphate 10 mg/5mL solution

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ECG.
Body weight ranging from 55 to 100 kg and a BMI ≥ 18.5 and ≤ 30.0.

Sponsors & Collaborators

Mundipharma Research Limited
Industrylead

MeSH Terms

Interventions

Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Enrollment

84 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 16, 2016

Study Start

September 2015

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (9)

Study Arms (3)

MR902 50/0.5 mg

MR902 200/2 mg

IR morphine sulphate 10 mg/5mL solution

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (9)

Study Arms (3)

MR902 50/0.5 mg

MR902 200/2 mg

IR morphine sulphate 10 mg/5mL solution

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record