Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450223
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2024-06-04
Brief Title:
Bioequivalence Study of Perampanel Tablets 12 mg
Sponsor:
Humanis Saglık Anonim Sirketi
Organization:
Humanis Saglık Anonim Sirketi
Study Overview
Official Title:
An Open-label Balanced Randomized Two Treatment Two Sequence Two Period Two Way Cross-over Single Dose Bioequivalence Study of Perampanel Tablets 12 mg of Humanis Sağlık AŞ Turkey and Fycompa 12 mg Film-coated Tablets of Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Germany in Normal Healthy Adult Human Subjects Under Fasting Condition
Status:
COMPLETED
Status Verified Date:
2024-06
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:
An open-label balanced randomized two treatment two sequence two period two way cross-over single dose bioequivalence study of Perampanel Tablets 12 mg of Humanis Sağlık Aġ Turkey and Fycompa 12 mg film-coated tablets of Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Germany in normal healthy adult human subjects under fasting condition
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None