Healthy
Conditions
Keywords
Bioequivalence, Cmax, AUC
Brief summary
This study is intended to establish the equivalence of 2 formulations to the intended final market product. The formulations to compare are the capsule given to patients in the phase I and II studies and the capsule that is being administered to the patients in the phase III trials. Both capsules will be compared to the intended final market capsule. The comparison will be performed looking at the pharmacokinetic parameters that define the rate and extent of absorption, those are Cmax and AUC. A statistical analysis will be performed comparing these parameters calculated after a single 125 mg dose of the 3 capsules identifying like that if there are significant differences between these 3 formulations.
Interventions
DRUGpalbociclib capsule: phase 1 and 2 studies
125 mg dose of palbociclib. Formulation used in phase 1 and 2 studies
DRUGPalbociclib capsule: phase 3 studies
125 mg dose of palbociclib. Formulation used in phase 3 studies
DRUGPalbociclib capsule: ICH
125 mg dose of palbociclib. Intended final market formulation
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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 criteria
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. * Any condition possibly affecting drug absorption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | 7 days | 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). |
| Maximum Observed Plasma Concentration (Cmax) | 7 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to 72 hrs [AUC (0-72)] | 3 days | AUC (0-72)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hrs(0-72) |
| Apparent Oral Clearance (CL/F) | 7 days | 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. |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 7 days | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) |
| Apparent Volume of Distribution (Vz/F) | 7 days | 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. |
| Plasma Decay Half-Life (t1/2) | 7 days | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] | 7 days | AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t) |
Countries
United States
Outcome results
None listed