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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
[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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IN-A012 | Experimental | Intravenous administration of IN-A012 |
|
| Akynzeo capsules | Active Comparator | Single oral administration of Akynzeo capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IN-A012 | Drug | The subjects will be given IN-A012 by Intravenous infusion over 30 minutes. |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seunghoon Han | The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic Univ. of Seoul St. Mary's Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| C000595957 | netupitant, palosentron drug combination |
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| Akynzeo 300Mg-0.5Mg Capsule |
| Drug |
The subjects will be administrated Akynzeo by Orally with water. |
|
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 |