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A Study to Compare Two Tablet Forms of Tafamidis in Healthy Participants

NCT05482308 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-05-23

Study results available
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Summary

The purpose of this clinical trial is to compare the amount of tafamidis in blood after taking two different tablet forms of tafamidis

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

All participants in the study will receive one tablet of study medicine on the first day, then receive one dose of the other tablet form 16 days later.

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

Participants will take part in this study for about 80 days. The first visit is a screening visit to ensure that participants are appropriate for the study. Up to 28 days later, they will visit the study clinic twice (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)

Variant 12.2 mg tafamidis free acid tablet (Test)

DRUG

Tafamidis free acid tablet (Reference)

Proposed commercial 12.2 mg tafamidis free acid tablet (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
2022-08-29
Primary Completion
2022-10-28
Completion
2022-10-28
FDA Drug
Yes

Countries

  • Belgium

Study Locations

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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 NCT05482308 on ClinicalTrials.gov