Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT06457204
Status:
COMPLETED
Last Update Posted:
2025-08-28
First Post:
2024-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study in Healthy People to Compare Two Different Sifrol® Tablets
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Bioequivalence of Two Sifrol® Tablets Following Oral Administration in Healthy Subjects (an Open-label, Randomised, Single-dose, Two-way Crossover Trial)
Status:
COMPLETED
Status Verified Date:
2025-08
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 Sifrol® tablets manufactured at two different sites.
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?: