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A Study to Determine the Bioequivalence of Two Doses of Tafamidis

NCT04575116 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-03-08

No results posted yet for this study

Summary

Study to characterize the bioequivalence of a 12.2 mg free acid tablets compared to commercial supply (tafamidis meglumine soft gelatin 20 mg capsule) in healthy participants under fasted conditions.

Conditions

  • Healthy

Interventions

DRUG

Tafamidis free acid tablet

12.2 mg tafamidis free acid tablet

DRUG

Tafamidis meglumine capsule

20 mg tafamidis meglumine soft gelatin capsule

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
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-17
Primary Completion
2021-02-23
Completion
2021-02-23
FDA Drug
Yes

Countries

  • United States

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 NCT04575116 on ClinicalTrials.gov