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Also known as palbociclib commercial free base capsule
palbociclib commercial free base · 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 |
|---|---|---|
| Cohort 1: Palbociclib under fed conditions | EXPERIMENTAL | - |
| Cohort 2: Palbociclib under fed conditions | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| palbociclib commercial free base | DRUG | 125 mg oral capsule single dose |
| famotidine | DRUG | 20 mg oral tablet 10 hours before and 2 hours after palbociclib |
| rabeprazole | DRUG | 2 x 20 mg oral tablets daily for 6 days then on 7th day, 4 hours after palbociclib |
| antacid | DRUG | 30 mL orally once (2h before palbociclib) |
Inclusion Criteria: * Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * Willing and able to comply with all scheduled visits, treatment plan, l...
Palbociclib commercial free base is the active free base form of palbociclib, a small molecule drug developed by Pfizer, Inc. (PFE). It is also known as palbociclib commercial free base capsule. The free base is the unmodified form of the drug substance used in the commercial capsule formulation.
Palbociclib commercial free base targets CDK4, CDK6, and CCND1. It acts as an inhibitor of these targets. CDK4 and CDK6 are cyclin-dependent kinases, and CCND1 is cyclin D1, which together regulate cell cycle progression.
Palbociclib commercial free base is made by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the developer of the palbociclib commercial free base capsule.
Palbociclib commercial free base is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. The only listed trial is a completed Phase 1 study.
Palbociclib commercial free base has been studied in one completed Phase 1 trial, NCT02097329, titled "Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food." The trial enrolled 27 healthy volunteers in the United States and was controlled but not randomized or double-blind.
Yes, palbociclib commercial free base is also known as palbociclib commercial free base capsule. The capsule refers to the commercial oral dosage form containing the free base of palbociclib.