A Study to Establish the Bioequivalence of Free Acid Tafamidis 61 mg Capsule and Tablet, and Evaluate the Safety and Tolerability of the 61 mg Tablet in Healthy Adults Under Fed Conditions

Start 16 Mar 2026 · Status Ongoing, recruitment ended · 1 EU/EEA countries · 1 sites · Protocol B3461131

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Bioequivalence study

Status Ongoing, recruitment ended

Participants planned 24

Countries 1

Sites 1

Transthyretin amyloidosis

Key facts

Sponsor: Pfizer Inc.
Participant type: Healthy volunteers
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Pathological Conditions, Signs and Symptoms [C23], Diseases [C] - Musculoskeletal Diseases [C05]
Trial duration: 16 Mar 2026 → ongoing
Decision date (initial): 2026-03-11
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Transthyretin amyloidosis

Version	Level	Code	Term	System organ class
20.0	PT	10002022	Amyloidosis	100000004870

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation: Pfizer Inc.
Address: 66 Hudson Boulevard East
City: New York
Postcode: 10001-2189
Country: United States

Scientific contact point

Organisation: Pfizer Inc.
Contact name: Clinical Medical Lead

Public contact point

Organisation: Pfizer Inc.
Contact name: Clinical Medical Lead

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Belgium	Ongoing, recruitment ended	24	1
Rest of world	—	0	—

Investigational sites

Belgium

1 site · Ongoing, recruitment ended

Pfizer Clinical Research Unit

N/A, Route de Lennik 808, B-1070, Brussels

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Belgium	2026-03-16		2026-03-23	2026-03-27

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2026-02-05	Belgium	Acceptable with conditions 2026-03-11	2026-03-11
2	SUBSTANTIAL MODIFICATION	SM-1	2026-03-23	Belgium	Acceptable 2026-04-03	2026-04-03