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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04486157
• Other study ID #: IN_FNP_101
• Status: Completed
• Phase: Phase 1
• Start date: March 18, 2021
• Est. completion date: May 10, 2021

Study information

• Verified date: May 2021
• Source: HK inno.N Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 10, 2021
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• IN-A012
The subjects will be given IN-A012 by Intravenous infusion over 30 minutes.
• Akynzeo 300Mg-0.5Mg Capsule
The subjects will be administrated Akynzeo by Orally with water.

Locations

Country	Name	City	State
Korea, Republic of	Catholic Univ. of Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
HK inno.N Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-t of netupitant	Area under the plasma concentration versus time curve 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
Secondary	Cmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron	Peak Plasma Concentration of fosnetupitant, 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
Secondary	tmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron	Time to reach maximum (peak) plasma concentration 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