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A Phase 1, Open-Label, Three Period Randomized, Single Dose Study To Estimate The Relative Bioavailability Of Pf-06291826 (Tafamidis) Free Acid Tablet Formulation Versus Commercial Capsule In Healthy Subjects Under Fasted Conditions
3 different formulations and doses of tafamidis will be compared. Subjects will be fasted for each test and every subject will test all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for 6 days. After 14 days, subjects will take a different formulation of tafamidis and tafamidis blood concentrations will be measured periodically for 6 days. After another 14 days, the last formulation will be tested in the same way.
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 12 |
| Start date | 2016-04 |
| Completion | 2016-06 |
Conditions
- Healthy
Interventions
- tafamidis
Primary outcomes
- Area under the concentration-time Curve (AUC) — 120 hours
- Maximum Observed Plasma Concentration (Cmax) — 120 hours
Countries
Belgium