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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Active Comparator | treatment A, reference, 20 micron palbociclib and lubrication level 1 |
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| Treatment B | Active Comparator | treatment B, test, 50 micron palbociclib and lubrication level 1 |
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| Treatment C | Active Comparator | treatment C, test, 20 micron palbociclib and lubrication level 2 |
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| Treatment D | Active Comparator | treatment D, test, 20 micron palbociclib and lubrication level 3 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palbociclib Formulation Reference | Other | Single 45 mg dose; Dosage form is capsule taken orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Concentration-Time Curve (AUC) from time zero extrapolate to infinite time | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. | 7 days |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] | AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t) | 7 days |
| Maximum Observed Plasma Concentration (Cmax) | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | 7 days |
| Area under the Concentration-Time Curve (AUC) from 0 to 72 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Palbociclib Formulation Test | Other | Single 45 mg dose; Dosage form is capsule taken orally. |
|
| Palbociclib Formulation Test | Other | Single 45 mg dose; Dosage form is capsule taken orally. |
|
| Palbociclib Formulation Test | Other | Single 45 mg dose; Dosage form is capsule taken orally. |
|
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. |
| 3 days |
| Apparent Oral Clearance (CL/F) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | 7 days |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 2 days |
| Apparent Volume of Distribution (Vz/F) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | 7 days |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 7 days |