Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360081
Status:
COMPLETED
Last Update Posted:
2024-07-09
First Post:
2024-04-08
Brief Title:
A Study in Healthy People to See How Zongertinib is Taken up Into the Blood When Given as Tablets Made by Two Different Manufacturers
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Bioequivalence of Zongertinib Tablets From Two Different Manufacturers Following Oral Administration in Healthy Male and Female Subjects an Open-label Randomised Single-dose Two-period Two-sequence Crossover Trial
Status:
COMPLETED
Status Verified Date:
2024-07
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 zongertinib tablet from manufacturer 1 Test T compared with zongertinib tablet from manufacturer 2 reference R following oral 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 |
|---|---|---|---|
| 2023-510495-31-00 | OTHER | None | None |
| U1111-1303-4345 | OTHER | WHO | None |