A Phase 1 interventional study of 4 mg 12 hourly capsule - strong pain killer fasted and 4 mg 12 hourly capsule - strong pain killer fed in Pain, sponsored by Mundipharma Research Limited. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-27.
Sponsored by Mundipharma Research Limited · Phase 1 and Interventional
To assess whether an opioid antagonist has any impact on the release of a strong painkiller in the blood when it is given to healthy volunteers when they have eaten and also when they have fasted.
This is an exploratory study to assess the influence of an opioid antagonist on the pharmacokinetics of a strong painkiller when co-administered in a fasted and fed state.
Determination is by measurement of drug concentrations in the blood at serial collection time points pre-dose until 32 hours post-dose, following an administration of a single oral dose. Pharmacokinetics parameters of AUC and Cmax are the primary endpoints.
Mundipharma Research Limited is the lead sponsor of 36 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy male or female subjects aged 18 to 55 inclusive Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ECG.
4 mg 12 hourly capsule - strong pain killer fasted
Drug: 4 mg 12 hourly capsule - strong pain killer fed
4 mg 12 hourly capsule - strong pain killer fed
Drug: 4 mg 12 hourly capsule - strong pain killer fasted
4 mg 12 hourly capsule strong painkiller with antagonist fasted
Drug: 4 mg 12 hourly capsule strong painkiller with antagonist fed
4 mg 12 hourly capsule strong painkiller with antagonist fed
Drug: 12 hourly capsule strong painkiller with antagonist fasted)
Also known as: MR2XXX
Also known as: MR2XXX
Also known as: MR2XXX
Also known as: MR2XXX
Pharmacokinetics parameters AUC and Cmax
Time frame: Up to 32 hours
Adverse Events
AEs will be recorded through spontaneous reporting
Time frame: 7 to 10 days
Vital Signs
Vital signs - blood pressure, pulse rate, tympanic temperature and respiration rate
Time frame: 0 to 32 hours
Clinical Laboratory Tests
Clinical laboratory tests - blood samples will be taken at screening and post-study medical for routine laboratory analysis (haematology, blood chemistry and urinalysis
Time frame: Day 0 and Day 7-10
ECG
ECGs
Time frame: Screening, 1 our post-dose and Day 7-10
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Mundipharma Research Limited