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

NCT04486157 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-06-01

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

IN-A012

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

DRUG

Akynzeo 300Mg-0.5Mg Capsule

The subjects will be administrated Akynzeo by Orally with water.

Sponsors & Collaborators

  • HK inno.N Corporation

    lead INDUSTRY

Principal Investigators

  • Seunghoon Han · The Catholic University of Korea

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-18
Primary Completion
2021-04-26
Completion
2021-05-10

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04486157 on ClinicalTrials.gov