The purpose of this study is to confirm pharmacokinetic equivalence and compare clinical safety profile of RPH-001 and Avastin®.
The study will be conducted in one specialized clinical site in Russia. It is planned to randomize 80 healthy male volunteers in this study. After screening period, not exceeding 15 days, all eligible subjects will be hospitalized to the site and randomized to receive RPH-001 or Avastin in 1:1 ratio. After a single-dose of investigational drugs administration subjects will remain under the observation in clinical site for 8 days and then will be discharged. The out-patient follow up period will include at least 8 scheduled subject's visits to the site. The study will consider completed for each subject at Day 100 visit after all clinical study procedures completion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
SBHI Krasnogorskaya City Hospital #1
Krasnogorsk, Russia
Cmax
Maximum concentration of investigational drug achieved during sampling
Time frame: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion
AUC(0-t)
Area Under the Concentration-time curve from time 0 to the time of the last sample with measurable concentration
Time frame: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion
AUC(0-∞)
Area Under the Concentration-time curve from time 0 extrapolated to infinite time
Time frame: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion
tmax
Time at which Cmax is attained
Time frame: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion
t1/2
The terminal half-life
Time frame: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after after the start of investigational product infusion
λz
Elimination rate constant
Time frame: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion
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Vz
Apparent Volume of Distribution
Time frame: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion