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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 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 73 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01906125
The ClinicalTrials.gov registry entry for NCT01906125 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which palbociclib capsule: phase 1 and 2 studies is the first listed.
NCT01906125 reports 0 study locations.
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.
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