Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-25 @ 4:23 PM
Study NCT ID:
NCT04486157
Status:
COMPLETED
Last Update Posted:
2021-06-01
First Post:
2020-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects
Sponsor:
HK inno.N Corporation
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* Primary Parameter
\- AUC0-t
* Secondary Parameters - Cmax, tmax
\[Safety Assessment\]
\- Adverse events, vital signs, physical examination, 12-lead ECGs, and clinical laboratory tests
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: