Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-10 @ 5:07 PM
Study NCT ID:
NCT03505151
Status:
COMPLETED
Last Update Posted:
2024-08-20
First Post:
2018-04-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
This Study in Healthy Men and Women Tests How the Body Takes up BI 409306
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Absolute Bioavailability and Pharmacokinetics of BI 409306 Using a Single Oral Dose of BI 409306 Co-administered With an Intravenous Stable Labeled Isotope BI 409306 (C-13/N-15) in Healthy Male and Female Subjects (Non-Randomised, Open-label, Single Arm, Single Period Design)
Status:
COMPLETED
Status Verified Date:
2024-04
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 primary objective of this trial is to investigate the absolute bioavailability of BI 409306. The secondary objective is the evaluation and comparison of several pharmacokinetic parameters for the different treatments.
Detailed Description:
None
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-004798-14 | EUDRACT_NUMBER | None | View |