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A Study to Compare the Amount of Two Forms of Tafamidis in the Blood of Healthy Adults Under Fed Conditions | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

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

A PHASE 1, OPEN-LABEL, RANDOMIZED, CROSSOVER, SINGLE DOSE, PIVOTAL BIOEQUIVALENCE STUDY TO COMPARE TAFAMIDIS FREE ACID TABLET AND COMMERCIAL TAFAMIDIS FREE ACID CAPSULE ADMINISTERED UNDER FED CONDITIONS IN HEALTHY ADULT PARTICIPANTS

NCT07470866•Pfizer

View on ClinicalTrials.gov

Summary

The purpose of this clinical trial is to compare the amount of tafamidis in the blood of healthy adult participants after taking two different forms of tafamidis by mouth under fed conditions.

Detailed Description

This study will be a Phase 1, open-label, randomized, two-treatment, two-period, crossover, single dose bioequivalence study to compare 61 mg tafamidis free acid tablet (Test) to 61 mg tafamidis free acid capsule (Reference) administered under fed conditions in healthy adult participants.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Age and Sex:
•1. 18 years of age or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
•2. BMI of 16-32 kg/m2; and a total body weight \>45 kg (99 lb).
•3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria

•Medical Conditions:
•1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
•* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
•* History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAb or HCVAb. Hepatitis B vaccination is allowed.
•* Hypersensitivity to any component of the formulations.
•2. Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
•Prior/Concomitant Therapy:
•3. Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
•4. Use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
•Prior/Concurrent Clinical Study Experience:
+12 more criteria

Key Dates

Start Date

March 27, 2026

Primary Completion Date

June 6, 2026

Completion Date

June 6, 2026

Last Updated

March 19, 2026

Enrollment

ESTIMATED participants

Conditions

Healthy

Interventions

Tafamidis (Reference)

DRUG

Tafamidis (Test)

DRUG

Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Collection of Data and Samples From Healthy Donors for Use in Translational Research

Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

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