Last reviewed · How we verify
A Phase 1, Open-label 6 Sequence 3 Period Crossover Study of Palbociclib (PD- 0332991) in Healthy Volunteers to Estimate the Relative Bioavailability of Palbociclib Formulations
A relative bioavailability study of commercial palbociclib free base hard capsules to the isethionate salt palbociclib capsules ( used in Phase 1 and 2 studies) under different fasting conditions.
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 36 |
| Start date | 2014-01 |
| Completion | 2014-03 |
Conditions
- Healthy
Interventions
- palbociclib isethionate (phase 1 and 2 studies)
- palbociclib isethionate (phase 1 and 2 studies)
- palbociclib commercial free base capsule
Primary outcomes
- 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
Countries
United States