A Phase 1, Open-label, Randomized, Crossover, Oral, Single Dose Study To Estimate The Relative Bioavailability Of Pf-06291826 (Tafamidis) Following Administration Of A Tafamidis Free Acid Tablet Formulation In Healthy Subjects Under Fasted And Fed Conditions

NCT02406560 Phase 1 COMPLETED

Each subject will be given tafamidis after either a high fat meal or while fasted. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for one week. After about 14 days, subjects will take either a different dose of tafamidis or the same dose under the opposite meal condition. Tafamidis concentrations from the three different conditions will be compared to determine if they are approximately the same.

Details

Lead sponsor	Pfizer
Phase	Phase 1
Status	COMPLETED
Enrolment	12
Start date	2015-04
Completion	2015-06

Conditions

• Healthy Volunteers

Interventions

• tafamidis
• tafamidis
• tafamidis

Primary outcomes

• Area under the Concentration-Time Curve (AUC) — 168 hours
  AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
• Maximum Observed Plasma Concentration (Cmax) — 168 hours

Countries

Belgium