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
Status | Completed |
Enrollment | 84 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - 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. - Willing to eat all the food supplied throughout the study. - The subject's primary care physician has confirmed within the last 12 months of first dosing that there is nothing in their medical history that would preclude their enrolment into a clinical study. Exclusion Criteria: - Female subjects who are pregnant or lactating. - Any history of drug or alcohol abuse, misuse, physical or psychological dependence. - Any history of conditions that might interfere with drug absorption, distribution, metabolism or excretion. - Use of opioid or opioid antagonist-containing medication in the past 30 days. - Any history of frequent nausea or vomiting regardless of etiology. - Any history of seizures or symptomatic head trauma. - History of respiratory depression, hypoxia or elevated carbon dioxide levels in the blood. - History of paralytic ileus, gastrointestinal disease or other clinically significant gastrointestinal problems. - Participation in a clinical drug study during the 90 days preceding the initial dose in this study. - Any significant illness during the 4 weeks preceding entry into this study. - Use of any medication including vitamins, herbal and/or mineral supplements during the 7 days preceding the initial dose or during the course of this study (with the exception of the continued use of HRT and contraceptives). - History of smoking within 60 days of IMP administration and refusal to abstain from smoking during the study. |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Mundipharma Research Limited |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measure the observed maximum plasma or serum concentration after administration (Cmax) | PK plasma parameters | Pre-dose to 24 hours post-dose | No |
Primary | 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 | No |
Secondary | measurement of Pharmacokinetic parameter Area under the curve to infinity after administration (AUCINF) | PK plasma parameters | Pre-dose to 24 hours post-dose | No |
Secondary | measurement of Pharmacokinetic parameter time to maximum concentration after administration (tmax) | PK plasma parameters | Pre-dose to 24 hours post-dose | No |
Secondary | measurement of Pharmacokinetic parameter of elimination rate after administration (LambdaZ,) | PK plasma parameters | Pre-dose to 24 hours post-dose | No |
Secondary | Measurement of Pharmacokinetic parameter elimination of half life after administration ( t1/2Z) | PK plasma parameters | Pre-dose to 24 hours post-dose | No |
Secondary | Measurement of heart rate | Vital signs measurements | Pre-dose to 24 hours post-dose | No |
Secondary | Measurement of blood pressure | vital signs measurement | pre-dose to 24 hours post-dose | No |
Secondary | Measurement of respiration rate | vital signs measurement | pre-dose to 24 hours post-dose | No |
Secondary | Measurement of temperature | vital signs measurement | pre-dose to 24 hours post-dose | No |
Secondary | Measurement of Saturation Pulse Oxygen (SP02) | vital signs measurement | pre-dose to 24 hours post-dose | No |
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