Clinical trial NCT04486157: Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2020-07-24
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: AUC0-t of netupitant
timeFrame: 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 outcomes:
measure: Cmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron
timeFrame: 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: tmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron
timeFrame: 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
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Catholic Univ. of Seoul St. Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Seunghoon Han
role: PRINCIPAL_INVESTIGATOR
References: