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CompletedNCT04486157Updated Jun 1, 2021

Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects

A Phase 1 interventional study of IN-A012 and Akynzeo 300Mg-0.5Mg Capsule in Healthy, sponsored by HK inno.N Corporation. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-01.

Sponsored by HK inno.N Corporation · Phase 1, Interventional, and Supportive care

Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
19 Years to 45 Years
Sex
All
01

Study summary

The main purpose of this study is to demonstrate the bioequivalence between IN-A012 and Akynzeo capsules by pharmacokinetic(PK) evaluation

Read the 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
02

Conditions studied

  • Healthy
03

In context

Lead sponsor

HK inno.N Corporation is the lead sponsor of 99 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 45 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    IN-A012

    Intravenous administration of IN-A012

    Drug: IN-A012

  • Active comparator
    Akynzeo capsules

    Single oral administration of Akynzeo capsules

    Drug: Akynzeo 300Mg-0.5Mg Capsule

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.

06

What researchers measure

Primary outcomes

  1. AUC0-t of netupitant

    Area under the plasma concentration versus time curve 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

Secondary outcomes

  1. Cmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron

    Peak Plasma Concentration of fosnetupitant, netupitant metabolites and palonosetron

    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

  2. tmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron

    Time to reach maximum (peak) plasma concentration of fosnetupitant, netupitant, netupitant metabolites and palonosetron

    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

07

Study locations

1 site
  • Catholic Univ. of Seoul St. Mary's Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04486157
Lead sponsor
HK inno.N Corporation
Responsible party
Sponsor
First posted
Jul 24, 2020
Start date
Mar 18, 2021
Primary completion
Apr 26, 2021
Completion
May 10, 2021
Last update
Jun 1, 2021

Study contacts

Seunghoon Han
principal investigator · The Catholic University of Korea

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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