Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2026-01-04 @ 4:24 PM
Study NCT ID:
NCT02841150
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2016-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Bioequivalence of Ibrutinib 560- Milligram (mg) Tablet to Four 140 -mg IMBRUVICA Capsules
Sponsor:
Janssen Research & Development, LLC
Organization:
Study Overview
Official Title:
A Single-Dose, Open-Label, Randomized, Replicate Crossover Study in Healthy Adult Subjects to Assess the Bioequivalence of an Ibrutinib 560-mg Tablet Compared to the Four IMBRUVICA 140 mg Capsules
Status:
COMPLETED
Status Verified Date:
2018-03
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 purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|---|
| 54179060CLL1021 | OTHER | Janssen Research & Development, LLC | View |