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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
16
Quotient Clinical Limited
Nottingham, Nottinghamshire, United Kingdom
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 platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.