Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450184
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2024-06-04
Brief Title:
Bioequivalence Study of Pimavanserin 34 mg Capsule
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 Pimavanserin 34 mg Capsule of Humanis Sağlık AŞ Turkey and NUPLAZID Pimavanserin Capsules of Acadia Pharmaceuticals Inc San Diego CA 92130 USA 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 Pimavanserin 34 mg Capsule of Humanis Sağlık AŞ Turkey and NUPLAZID Pimavanserin capsules of Acadia Pharmaceuticals Inc San Diego CA 92130 USA 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