MedTrace Logo

A Study Comparing Two Forms of Tafamidis Without Food and the Amount of Tafamidis in the Blood With Food

NCT05498701 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-06-03

Study results available
· View outcomes & findings →

Summary

The purpose of this clinical trial is to compare a tablet and a capsule form of tafamidis without food and to assess the amount of tafamidis in blood after taking the tablet form with food.

This study is seeking healthy participants over the age of 18.

All participants in the study will receive either one tablet or capsule of study medicine on the first day without food, then receive one dose of the other tablet or capsule form 16 days later without food. All participants will then receive one dose of the tablet form with food 16 days later.

We will evaluate the amounts in blood for 8 days after taking each dose of the study medicine.

Participants will take part in this study for about 96 days. The first visit is a screening visit to ensure that participants are appropriate for the study. Up to 28 days later, eligible participants will visit the study clinic three times (and stay overnight in the clinical research center for 8 nights each time). The study team will also call participants over the phone 28 to 35 days after the last dose of medicine.

Conditions

  • Healthy

Interventions

DRUG

Tafamidis free acid tablet (Test)

12.2 mg tafamidis free acid tablet (Test)

DRUG

Tafamidis meglumine capsule (Reference)

Commercial 20 mg tafamidis meglumine capsule (Reference)

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-29
Primary Completion
2022-12-18
Completion
2022-12-19
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05498701 on ClinicalTrials.gov