A study to assess bioavailability of a single dose of MR902 and to assess the effect of food on absorption
Volunteers will receive a single dose of the investigational drug on 2 occasions and a reference drug on 1 occasion. Volunteers will be randomised to one of two groups, each group receiving a different dose strength of MR902 in fed and fasted state. The study involves a screening visit 21 days before first dosing and 3 overnight stays in 3 study periods, and a post-study medical visit. Volunteers will receive naltrexone to reduce anticipated opioid side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Measure the observed maximum plasma or serum concentration after administration (Cmax)
PK plasma parameters
Time frame: 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
Time frame: Pre-dose to 24 hours post-dose
measurement of Pharmacokinetic parameter Area under the curve to infinity after administration (AUCINF)
PK plasma parameters
Time frame: Pre-dose to 24 hours post-dose
measurement of Pharmacokinetic parameter time to maximum concentration after administration (tmax)
PK plasma parameters
Time frame: Pre-dose to 24 hours post-dose
measurement of Pharmacokinetic parameter of elimination rate after administration (LambdaZ,)
PK plasma parameters
Time frame: Pre-dose to 24 hours post-dose
Measurement of Pharmacokinetic parameter elimination of half life after administration ( t1/2Z)
PK plasma parameters
Time frame: Pre-dose to 24 hours post-dose
Measurement of heart rate
Vital signs measurements
Time frame: Pre-dose to 24 hours post-dose
Measurement of blood pressure
vital signs measurement
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Time frame: pre-dose to 24 hours post-dose
Measurement of respiration rate
vital signs measurement
Time frame: pre-dose to 24 hours post-dose
Measurement of temperature
vital signs measurement
Time frame: pre-dose to 24 hours post-dose
Measurement of Saturation Pulse Oxygen (SP02)
vital signs measurement
Time frame: pre-dose to 24 hours post-dose