Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects
Study Details
Study Description
Brief Summary
The main purpose of this study is to demonstrate the bioequivalence between IN-A012 and Akynzeo capsules by pharmacokinetic(PK) evaluation
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Detailed Description
[Pharmacokinetics Assessment]
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Primary Parameter
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AUC0-t
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Secondary Parameters - Cmax, tmax
[Safety Assessment]
- Adverse events, vital signs, physical examination, 12-lead ECGs, and clinical laboratory tests
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: IN-A012 Intravenous administration of IN-A012 |
Drug: IN-A012
The subjects will be given IN-A012 by Intravenous infusion over 30 minutes.
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Active Comparator: Akynzeo capsules Single oral administration of Akynzeo capsules |
Drug: Akynzeo 300Mg-0.5Mg Capsule
The subjects will be administrated Akynzeo by Orally with water.
|
Outcome Measures
Primary Outcome Measures
- AUC0-t 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]
Area under the plasma concentration versus time curve of netupitant
Secondary Outcome Measures
- Cmax 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]
Peak Plasma Concentration of fosnetupitant, netupitant metabolites and palonosetron
- tmax 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]
Time to reach maximum (peak) plasma concentration of fosnetupitant, netupitant, netupitant metabolites and palonosetron
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy adults aged between 19-45
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Body weight ≥ 50kg and in the range of ideal body weight ± 20%
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Without congenital, or chronic diseases within recent 5 years
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Subjects who are deemed eligible based on the screening tests
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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
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Agree to use acceptable contraceptive methods from signing the informed consent to 3 weeks after the last dose of the investigational product
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Able and willing to comply with study requirements including all scheduled inpatient and outpatient visits, clinical laboratory tests, and instructions.
Exclusion Criteria:
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A subject with symptoms suspected of acute illness at the screening
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A subject with clinically significant and active cardiovascular, respiratory, kidney, endocrine, hematological, gastrointestinal, central nervous system diseases, psychiatric disorders, or malignant tumors
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A history of gastrointestinal disease
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Known hypersensitivity to the active ingredient or excipients of investigational product or a history of clinically significant hypersensitivity
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A history of drug abuse
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Pregnant women or women who may be pregnant, and breastfeeding women
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Subjects who are deemed inappropriate to participate in the study by the investigator for other reasons
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Catholic Univ. of Seoul St. Mary's Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- HK inno.N Corporation
Investigators
- Principal Investigator: Seunghoon Han, The Catholic University of Korea
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IN_FNP_101