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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 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 24 participants.

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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.

Interventions

  • OTHER Palbociclib Formulation Reference
  • OTHER Palbociclib Formulation Test

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2013-06
Est. Completion 2013-08
Phase Phase 1

Sponsor

Pfizer

1,845 total trials

What the Registry Record Tells You About NCT01844323

The ClinicalTrials.gov registry entry for NCT01844323 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 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 2 interventions - of which Palbociclib Formulation Reference is the first listed.

NCT01844323 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.