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A Phase 1, Single Dose, Fixed Sequence, 2-Period Cross-Over Absolute Oral Bioavailability Study In Healthy Volunteers Comparing Oral To Intravenous Administration Of PD-0332991
The purpose of this study is to determine approximately what percentage of an orally administered dose of PD-0332991 is absorbed from the gastrointestinal tract into the systemic circulation. This approximation is made by comparing the plasma pharmacokinetics of a 125 mg oral dose of PD-0332991 to the plasma pharmacokinetics of a 50 mg intravenous dose of PD-0332991 administered as a 4-hour infusion.
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 14 |
| Start date | 2013-05 |
| Completion | 2013-06 |
Conditions
- Healthy
Interventions
- Oral Drug Formulation of PD-0332991
- Intravenous Formulation of PD-0332991
Primary outcomes
- Dose-Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] — 0 to 144 hours
Dose-Normalized AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8) divided by the administered dose. It is obtained from AUC (0 - t) plus AUC (t - 8). - Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] — 0 to 144 hours
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).
Countries
United Kingdom