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NCT01906125 · ClinicalTrials.gov registry record · Phase 1
A Study To Establish The Equivalence Of 2 Palbociclib (PD-0332991) Formulations To The Intended Final Market Product
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 73
- Enrollment target
NCT01906125: Completed Phase 1 study, sponsored by Pfizer.
NCT01906125 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 73 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01906125, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 73 participants
- Enrollment target
Study Summary
This study is intended to establish the equivalence of 2 formulations to the intended final market product. The formulations to compare are the capsule given to patients in the phase I and II studies and the capsule that is being administered to the patients in the phase III trials. Both capsules will be compared to the intended final market capsule. The comparison will be performed looking at the pharmacokinetic parameters that define the rate and extent of absorption, those are Cmax and AUC. A statistical analysis will be performed comparing these parameters calculated after a single 125 mg dose of the 3 capsules identifying like that if there are significant differences between these 3 formulations.
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 capsule: phase 1 and 2 studies
- DRUG Palbociclib capsule: phase 3 studies
- DRUG Palbociclib capsule: ICH
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2013-09 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
What the finished NCT01906125 record still lists
NCT01906125 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher).
The record links to 0 conditions, and to 3 interventions - of which palbociclib capsule: phase 1 and 2 studies is the first listed.
NCT01906125 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01906125 about?
NCT01906125 is a clinical study titled "A Study To Establish The Equivalence Of 2 Palbociclib (PD-0332991) Formulations To The Intended Final Market Product". This study is intended to establish the equivalence of 2 formulations to the intended final market product. The formulations to compare are the capsule given to patients in the phase I and II studies and the capsule that is being administered to the patients in the phase III trials. Both capsules wi...
What is the current status of trial NCT01906125?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2013-09. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01906125?
The interventions under investigation include: palbociclib capsule: phase 1 and 2 studies (DRUG), Palbociclib capsule: phase 3 studies (DRUG), Palbociclib capsule: ICH (DRUG).
Who is sponsoring clinical trial NCT01906125?
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 NCT01906125's enrollment target sits among peer trials
73 732nd of 2000 higher than 1,265 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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