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NCT02083640 · ClinicalTrials.gov registry record · Phase 1
Relative Bioavailability For Palbociclib Formulations
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT02083640: Completed Phase 1 study, sponsored by Pfizer.
NCT02083640 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02083640, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study is to assess the relative bioavailability of palbociclib hard gelatin capsule formulation (API 41 micrometer and dissolution Level 1) and palbociclib hard gelatin capsule formulation (API 16 micrometer and dissolution Level 2) compared to the palbociclib hard gelatin capsule formulation (API 16 micrometer and dissolution Level 1) after single 125 mg oral doses under fed conditions in healthy volunteers.
Primary Outcome
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Interventions
- DRUG Palbociclib Formulation Reference
- DRUG Palbociclib Formulation Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-03 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT02083640 record still lists
NCT02083640 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Palbociclib Formulation Reference is the first listed.
NCT02083640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02083640 about?
NCT02083640 is a clinical study titled "Relative Bioavailability For Palbociclib Formulations". This study is to assess the relative bioavailability of palbociclib hard gelatin capsule formulation (API 41 micrometer and dissolution Level 1) and palbociclib hard gelatin capsule formulation (API 16 micrometer and dissolution Level 2) compared to the palbociclib hard gelatin capsule formulation (...
What is the current status of trial NCT02083640?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2014-03. Estimated completion is 2014-05.
What interventions are being tested in trial NCT02083640?
The interventions under investigation include: Palbociclib Formulation Reference (DRUG), Palbociclib Formulation Test (DRUG).
Who is sponsoring clinical trial NCT02083640?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02083640's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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