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NCT02877225 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Bioequivalence of Ibrutinib 140 Milligram (mg) Tablet to 140 mg IMBRUVICA Capsule
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 103
- Enrollment target
NCT02877225: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT02877225 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 103 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02877225, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 103 participants
- Enrollment target
Study 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.
Primary Outcome
Area under the concentration-time curve (AUC) from time 0 to the time of the last measurable (non-below quantification limit \[non-BQL\]) concentration, calculated by linear-linear trapezoidal summation.
Interventions
- DRUG Ibrutinib
- DRUG IMBRUVICA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2016-08-29 |
| Est. Completion | 2016-11-11 |
| Phase | Phase 1 |
What the finished NCT02877225 record still lists
NCT02877225 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% higher).
The record links to 0 conditions, and to 2 interventions - of which Ibrutinib is the first listed.
NCT02877225 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02877225 about?
NCT02877225 is a clinical study titled "Study to Assess the Bioequivalence of Ibrutinib 140 Milligram (mg) Tablet to 140 mg IMBRUVICA Capsule". 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.
What is the current status of trial NCT02877225?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 103 participants. The study started on 2016-08-29. Estimated completion is 2016-11-11.
What interventions are being tested in trial NCT02877225?
The interventions under investigation include: Ibrutinib (DRUG), IMBRUVICA (DRUG).
Who is sponsoring clinical trial NCT02877225?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02877225's enrollment target sits among peer trials
103 541st of 2000 higher than 1,458 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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