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

NCT ID: NCT04486157

Last Updated: 2021-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-18
• Study Completion Date: 2021-05-10

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

IN-A012

Intravenous administration of IN-A012

Group Type: EXPERIMENTAL

IN-A012

Intervention Type: DRUG

The subjects will be given IN-A012 by Intravenous infusion over 30 minutes.

Akynzeo capsules

Single oral administration of Akynzeo capsules

Group Type: ACTIVE_COMPARATOR

Akynzeo 300Mg-0.5Mg Capsule

Intervention Type: DRUG

The subjects will be administrated Akynzeo by Orally with water.

Interventions

IN-A012

The subjects will be given IN-A012 by Intravenous infusion over 30 minutes.

Intervention Type: DRUG

Akynzeo 300Mg-0.5Mg Capsule

The subjects will be administrated Akynzeo by Orally with water.

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HK inno.N Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seunghoon Han

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

Catholic Univ. of Seoul St. Mary's Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

IN_FNP_101

Identifier Type: -

Identifier Source: org_study_id