Healthy
Conditions
Brief summary
The main purpose of this study is to demonstrate the bioequivalence between IN-A012 and Akynzeo capsules by pharmacokinetic(PK) evaluation
Detailed description
\[Pharmacokinetics Assessment\] * Primary Parameter \- AUC0-t * Secondary Parameters - Cmax, tmax \[Safety Assessment\] \- Adverse events, vital signs, physical examination, 12-lead ECGs, and clinical laboratory tests
Interventions
DRUGIN-A012
The subjects will be given IN-A012 by Intravenous infusion over 30 minutes.
DRUGAkynzeo 300Mg-0.5Mg Capsule
The subjects will be administrated Akynzeo by Orally with water.
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adults aged between 19-45 2. Body weight ≥ 50kg and in the range of ideal body weight ± 20% 3. Without congenital, or chronic diseases within recent 5 years 4. Subjects who are deemed eligible based on the screening tests 5. 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 6. Agree to use acceptable contraceptive methods from signing the informed consent to 3 weeks after the last dose of the investigational product 7. Able and willing to comply with study requirements including all scheduled inpatient and outpatient visits, clinical laboratory tests, and instructions.
Exclusion criteria
1. A subject with symptoms suspected of acute illness at the screening 2. A subject with clinically significant and active cardiovascular, respiratory, kidney, endocrine, hematological, gastrointestinal, central nervous system diseases, psychiatric disorders, or malignant tumors 3. A history of gastrointestinal disease 4. Known hypersensitivity to the active ingredient or excipients of investigational product or a history of clinically significant hypersensitivity 5. A history of drug abuse 6. Pregnant women or women who may be pregnant, and breastfeeding women 7. Subjects who are deemed inappropriate to participate in the study by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed