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COMPLETED
NCT07587697
PHASE1

A Study to Compare the Amount of Two Forms of Tafamidis in the Blood of Healthy Adults Under Fasting Conditions

Sponsor: Pfizer

View on ClinicalTrials.gov

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

DRUG

Tafamidis

(Reference) 61 milligram (mg)free acid capsule

DRUG

Tafamidis

(Test 1) 61mg orally disintegrating tablet (ODT) with water

DRUG

Tafamidis

(Test 2) 61mg ODT without water

Locations (1)

P-One Clinic

Hachioji-shi, Tokyo, Japan