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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: IN-A012; Drug: Akynzeo 300Mg-0.5Mg Capsule

• Registration Number: NCT04486157
• Lead Sponsor: HK inno.N Corporation

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 Timeline

• Study First Submitted: 2020-07-17
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-24
• Study Start: 2021-03-18
• Primary Completion: 2021-04-26
• Status Verified: 2021-05
• Study Completion: 2021-05-10
• Last Update Submitted: 2021-05-28
• Last Update Posted: 2021-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IN-A012	IN-A012	Intravenous administration of IN-A012
Akynzeo capsules	Akynzeo 300Mg-0.5Mg Capsule	Single oral administration of Akynzeo capsules

Primary Outcome Measures

Name	Time	Method
AUC0-t 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	Area under the plasma concentration versus time curve of netupitant

Secondary Outcome Measures

Name	Time	Method
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	Peak Plasma Concentration of fosnetupitant, netupitant metabolites and palonosetron
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	Time to reach maximum (peak) plasma concentration of fosnetupitant, netupitant, netupitant metabolites and palonosetron

Trial Locations

Locations (1)

Catholic Univ. of Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of