Double-blind, single-dose, three-treatment, parallel group design PK comparability study of MYL-1402O solution manufactured for Mylan compared to US and EU marketed Avastin® solution (bevacizumab).
Double-blind, single-dose, three-treatment, parallel group design PK comparability study of MYL-1402O solution manufactured for Mylan compared to US and EU marketed Avastin® solution (bevacizumab) in a total of 111 healthy, adult male volunteers (37 subjects per treatment arm). After randomization, subjects will receive one of the following treatments: A single 1 mg/kg dose administered by i.v. infusion (25 mL over approximately 90 minutes) of MYL-1402O, an equivalent i.v. infusion of US marketed Avastin® (1 mg/kg), or an equivalent i.v. infusion of EU marketed Avastin® (1 mg/kg).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
111
Treatment A - single 1mg/kg dose of MYL-14020 IV infusion over 90 mins.
Treatment B - single 1mg/kg dose of US marketed Avastin® IV infusion over 90mins
Treatment C - single 1mg/kg dose of EU marketed Avastin® IV infusion over 90mins.
PRA Health Sciences - Early Development Services
Zuidlaren, Netherlands
Area under the plasma concentration versus time curve (AUC) for bevacizumab.
Area under the plasma concentration versus time curve (AUC) for bevacizumab
Time frame: pre-dose and 0.33, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, and 2352 hours after start of infusion.
Area under the plasma concentration versus time curve (AUC) for bevacizumab
Area under the plasma concentration versus time curve (AUC) for bevacizumab
Time frame: pre-dose and 0.33, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, and 2352 hours after start of infusion.
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