Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects

Study Overview
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Brief Summary
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The main purpose of this study is to demonstrate the bioequivalence between IN-A012 and Akynzeo capsules by pharmacokinetic(PK) evaluation

Detailed Description
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[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

Official Title
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A Phase 1, Open Label, Randomized, Single Dose, Two Treatment, Two Sequence, Two Period, Crossover Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: IN-A012
* Drug: Akynzeo 300Mg-0.5Mg Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged between 19-45 Body weight ≥ 50kg and in the range of ideal body weight ± 20% Without congenital, or chronic diseases within recent 5 years Subjects who are deemed eligible based on the screening tests Subjects who received a full explanation of the study, understood the purpose and details of this study, characteristics of the investigational product, and expected adverse events, and voluntarily signed the informed consent form Agree to use acceptable contraceptive methods from signing the informed consent to 3 weeks after the last dose of the investigational product Able and willing to comply with study requirements including all scheduled inpatient and outpatient visits, clinical laboratory tests, and instructions. Exclusion Criteria: A subject with symptoms suspected of acute illness at the screening A subject with clinically significant and active cardiovascular, respiratory, kidney, endocrine, hematological, gastrointestinal, central nervous system diseases, psychiatric disorders, or malignant tumors A history of gastrointestinal disease Known hypersensitivity to the active ingredient or excipients of investigational product or a history of clinically significant hypersensitivity A history of drug abuse Pregnant women or women who may be pregnant, and breastfeeding women Subjects who are deemed inappropriate to participate in the study by the investigator for other reasons

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IN-A012<br>Intravenous administration of IN-A012 | Drug: IN-A012<br>* The subjects will be given IN-A012 by Intravenous infusion over 30 minutes.<br>|
| Active Comparator: Akynzeo capsules<br>Single oral administration of Akynzeo capsules | Drug: Akynzeo 300Mg-0.5Mg Capsule<br>* The subjects will be administrated Akynzeo by Orally with water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-t of netupitant | Area under the plasma concentration versus time curve of netupitant | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron | Peak Plasma Concentration of fosnetupitant, netupitant metabolites and palonosetron | 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 | 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 |