NCT04486157

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-18
• Primary completion: 2021-04-26
• Completion: 2021-05-10
• First posted: 2020-07-24
• Last updated: 2021-06-01

Locations

1 site across 1 country: South Korea