NCT04486157
Completed
Phase 1
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
ConditionsHealthy
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- HK inno.N Corporation
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- AUC0-t of netupitant
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
IN-A012
Experimental
Intravenous administration of IN-A012
Intervention: IN-A012 (Drug)
Akynzeo capsules
Active Comparator
Single oral administration of Akynzeo capsules
Intervention: Akynzeo 300Mg-0.5Mg Capsule (Drug)
Outcomes
Primary Outcomes
AUC0-t 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
Area under the plasma concentration versus time curve of netupitant
Secondary Outcomes
- 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)
- 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)
Investigators
Study Sites (1)
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