The purpose of this to assess pharmacokinetic bioequivalence between two bevacizumab products, RPH-001 (TRPHARM) and EU sourced Avastin® (Roche), after single IV administration at 5 mg/kg fixed dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Avastin® has been approved for treatment of various cancers in many countries of the world including the USA, EU countries, and Turkey. In Turkey, Avastin® is approved with a different trade name, Altuzan®, for treatment of metastatic colorectal cancer.
R-Pharm created a biological analog of Avastin®, RPH-001. RPH-001 and Avastin® have similar physicochemical properties, pharmacokinetic profile and affinity to human vascular endothelial growth factor, similar toxicity and efficacy confirmed by preclinical study results.
Maximum plasma concentration
Cmax
Time frame: Until 100 days after administration
Area under concentration-time curve from time zero to the last sampling time
Area Under the Curve - AUC(0-t)
Time frame: Until 100 days after administration
Area under concentration-time curve from time zero to infinity
Area Under the Curve - AUC(0-∞)
Time frame: Until 100 days after administration
Concentration-time profiles
RPH-001 and Avastin®
Time frame: Until 100 days after administration
Time to maximum concentration (Tmax)
RPH-001 and Avastin®
Time frame: Until 100 days after administration
Terminal elimination half-life (t½)
RPH-001 and Avastin®
Time frame: Until 100 days after administration
Terminal elimination rate constant (λz)
RPH-001 and Avastin®
Time frame: Until 100 days after administration
Apparent volume of distribution (Vz)
RPH-001 and Avastin®
Time frame: Until 100 days after administration
Clearance (CL)
Time frame: Until 100 days after administration
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Volume of distribution at steady state (Vss)
Time frame: Until 100 days after administration
Nature, frequency, severity and relationship to study drug of recorded adverse events
Time frame: Until 100 days after administration
Physical examination
Time frame: Until 100 days after administration
Heart rate
Time frame: Until 100 days after administration
Blood Pressure
Time frame: Until 100 days after administration
Respiratory rate
Time frame: Until 100 days after administration
Oxygen saturation
Time frame: Until 100 days after administration
Body temperature
Time frame: Until 100 days after administration
ECG
Time frame: Until 100 days after administration
Clinical laboratory tests
Time frame: Until 100 days after administration
Anti-drug-antibody (ADA)
Time frame: Until 100 days after administration
Neutralizing antibody (NAb)
Time frame: Until 100 days after administration