Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT01426958
Status:
COMPLETED
Last Update Posted:
2014-06-09
First Post:
2011-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Relative Bioavailability of a Single Oral Dose of 40 mg Afatinib Given Alone Compared to Concomitant and Timed Administration of Multiple Oral Doses of Ritonavir - an Open-label, Randomised, Three-way Crossover Trial in Healthy Male Volunteers
Status:
COMPLETED
Status Verified Date:
2013-10
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:
To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK) of afatinib depending on the timepoint of ritonavir administration
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-001803-11 | EUDRACT_NUMBER | EudraCT | View |