The main purpose of this study is to demonstrate the bioequivalence between IN-A012 and Akynzeo capsules by pharmacokinetic(PK) evaluation
\[Pharmacokinetics Assessment\] * Primary Parameter \- AUC0-t * Secondary Parameters - Cmax, tmax \[Safety Assessment\] \- Adverse events, vital signs, physical examination, 12-lead ECGs, and clinical laboratory tests
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
44
The subjects will be given IN-A012 by Intravenous infusion over 30 minutes.
The subjects will be administrated Akynzeo by Orally with water.
Catholic Univ. of Seoul St. Mary's Hospital
Seoul, South Korea
AUC0-t of netupitant
Area under the plasma concentration versus time curve of netupitant
Time frame: pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose
Cmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron
Peak Plasma Concentration of fosnetupitant, netupitant metabolites and palonosetron
Time frame: pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose
tmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron
Time to reach maximum (peak) plasma concentration of fosnetupitant, netupitant, netupitant metabolites and palonosetron
Time frame: pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose
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