Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-29 @ 1:25 PM
Study NCT ID:
NCT02319057
Status:
COMPLETED
Last Update Posted:
2015-05-06
First Post:
2014-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of Single Doses of ORM-12741
Sponsor:
Orion Corporation, Orion Pharma
Organization:
Study Overview
Official Title:
Pharmacokinetic Study of Modified Release Formulations and an Immediate Release Formulation of ORM-12741 After Single Oral Doses
Status:
COMPLETED
Status Verified Date:
2015-05
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:
Nebula PK 1
Brief Summary:
The purpose of this study is to evaluate ORM-12741 concentrations in the blood after different study drug formulations
Detailed Description:
The purpose of this study is to evaluate the pharmacokinetics and safety of single doses of modified release formulations and a immediate release formulation of ORM-12741
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2014-000193-19 | EUDRACT_NUMBER | None | View |