Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408870
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2024-05-07
Brief Title:
A Study in Healthy People to Compare How 2 Different Low Dose Formulations of BI 1015550 Are Taken up in the Body
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Bioequivalence of the BI 1015550 Low Dose Formulation C2 and the BI 1015550 Low Dose Formulation C1 Phase 3 Formulation Following Oral Administration in Healthy Subjects an Open-label Randomised Single-dose Two-way Crossover Trial
Status:
COMPLETED
Status Verified Date:
2024-09
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 objective of this trial is to establish the bioequivalence of the BI 1015550 Formulation C2 Test T and the BI 1015550 Formulation C1 Reference R following a single oral dose administration
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-509951-15-00 | REGISTRY | None | None |
| U1111-1301-0913 | REGISTRY | WHO International Clinical Trials Registry Platform ICTRP | None |