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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 FASTED CONDITIONS IN HEALTHY ADULT PARTICIPANTS

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Trial Profile

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 FASTED CONDITIONS IN HEALTHY ADULT PARTICIPANTS

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 02 Jun 2025

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At a glance

  • Drugs Tafamidis meglumine (Primary)
  • Indications Amyloid polyneuropathy; Cardiomyopathies
  • Focus Pharmacokinetics
  • Sponsors Pfizer

Most Recent Events

  • 28 May 2025 Status changed from recruiting to completed.
  • 22 Jan 2025 Planned End Date changed from 3 Apr 2025 to 6 Mar 2025.
  • 22 Jan 2025 Planned primary completion date changed from 3 Apr 2025 to 6 Mar 2025.

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