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palbociclib isethionate · 1 trial · 1 indication
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).
| Arm | Type | Description |
|---|---|---|
| Palbociclib given to healthy volunteers | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| palbociclib isethionate (phase 1 and 2 studies) | DRUG | 125 mg palbociclib isethionate salt under overnight fasting conditions |
| palbociclib commercial free base capsule | DRUG | 125 mg palbociclib commercial free base capsule under fed conditions ( moderate fat meal) |
Inclusion Criteria: * Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years. * Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. Exclusion...
Palbociclib isethionate is a small molecule drug being developed by Pfizer, Inc. It is currently in Phase 1 clinical development. The drug has been studied in a completed clinical trial involving healthy volunteers to assess its relative bioavailability under fed and fasted conditions.
Palbociclib isethionate is being studied for use in healthy volunteers. The completed Phase 1 trial evaluated the relative bioavailability of the drug under fed and fasted conditions. This trial was not designed to treat a specific disease but to gather pharmacokinetic data in healthy individuals.
Palbociclib isethionate is developed by Pfizer, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development.
Palbociclib isethionate is in Phase 1 clinical development. It is an investigational drug, not yet approved for any medical use. The only completed trial was a Phase 1 study in healthy volunteers, and there are no active trials currently listed.
Palbociclib isethionate has one completed clinical trial, NCT02041273, titled 'Relative Bioavailability Of Palbociclib (PD-0332991) Under Fed And Fasted Conditions.' This Phase 1 study enrolled 36 healthy volunteers in the United States and was not randomized, double-blind, or controlled.