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A Study to Compare the Amount of Two Forms of Tafamidis in the Blood of Healthy Adults Under Fasting Conditions
Sponsor: Pfizer
Summary
The purpose of this clinical trial is to compare the blood tafamidis concentration of healthy adult participants after taking two different forms of tafamidis by under fasted conditions.
Official title: A PHASE 1, OPEN-LABEL, RANDOMIZED, THREE-TREATMENT, THREE-PERIOD, CROSSOVER, SINGLE DOSE, PIVOTAL BIOEQUIVALENCE STUDY TO COMPARE TAFAMIDIS FREE ACID ORALLY DISINTEGRATING TABLET AND COMMERCIAL TAFAMIDIS FREE ACID CAPSULE ADMINISTERED UNDER FASTED CONDITIONS IN HEALTHY ADULT PARTICIPANTS
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-05-11
Completion Date
2026-08-03
Last Updated
2026-08-31
Healthy Volunteers
Yes
Conditions
Interventions
Tafamidis
(Reference) 61 milligram (mg)free acid capsule
Tafamidis
(Test 1) 61mg orally disintegrating tablet (ODT) with water
Tafamidis
(Test 2) 61mg ODT without water
Locations (1)
P-One Clinic
Hachioji-shi, Tokyo, Japan