A Phase 1 interventional study of IN-A012 and Akynzeo 300Mg-0.5Mg Capsule in Healthy, sponsored by HK inno.N Corporation. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-01.
Sponsored by HK inno.N Corporation · Phase 1, Interventional, and Supportive care
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
[Safety Assessment]
HK inno.N Corporation is the lead sponsor of 99 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intravenous administration of IN-A012
Drug: IN-A012
Single oral administration of Akynzeo capsules
Drug: Akynzeo 300Mg-0.5Mg Capsule
The subjects will be given IN-A012 by Intravenous infusion over 30 minutes.
The subjects will be administrated Akynzeo by Orally with water.
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
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
HK inno.N Corporation