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NCT01844323 · ClinicalTrials.gov registry record · Phase 1
A Study In Healthy Volunteers To Estimate The Effect Of The Active Ingredient Particle Size And Percentage Of The Excipients Used To Formulate The Capsules In The Dissolution Rate Of The Formulations In The Gastrointestinal Tract
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01844323: Completed Phase 1 study, sponsored by Pfizer.
NCT01844323 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01844323, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The particle size of the active ingredient may impact dissolution rate in the gastro intestinal tract and hence the amount of drug available for absorption. Similarly, differences in the percentage of the excipients used in the formulated capsules may affect dissolution rate. The purpose of this study is to estimate the effect that particle size and percentage of excipients could have in drug absorption, which will improve the manufacturing process of the formulated capsules.
Primary Outcome
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Interventions
- OTHER Palbociclib Formulation Reference
- OTHER Palbociclib Formulation Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2013-06 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
What the finished NCT01844323 record still lists
NCT01844323 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Palbociclib Formulation Reference is the first listed.
NCT01844323 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01844323 about?
NCT01844323 is a clinical study titled "A Study In Healthy Volunteers To Estimate The Effect Of The Active Ingredient Particle Size And Percentage Of The Excipients Used To Formulate The Capsules In The Dissolution Rate Of The Formulations In The Gastrointestinal Tract". The particle size of the active ingredient may impact dissolution rate in the gastro intestinal tract and hence the amount of drug available for absorption. Similarly, differences in the percentage of the excipients used in the formulated capsules may affect dissolution rate. The purpose of this stu...
What is the current status of trial NCT01844323?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2013-06. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01844323?
The interventions under investigation include: Palbociclib Formulation Reference (OTHER), Palbociclib Formulation Test (OTHER).
Who is sponsoring clinical trial NCT01844323?
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 NCT01844323's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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