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A PHASE 1, OPEN-LABEL, RANDOMIZED, CROSSOVER, SINGLE DOSE STUDY TO DETERMINE THE BIOEQUIVALENCE OF 12.2 MG TAFAMIDIS FREE ACID TABLETS AND COMMERCIAL 20 MG TAFAMIDIS MEGLUMINE CAPSULES ADMINISTERED UNDER FASTED CONDITIONS AND THE EFFECT OF FOOD ON ORAL BIOAVAILABILITY OF 12.2 MG TAFAMIDIS FREE ACID TABLETS IN HEALTHY ADULT PARTICIPANTS

Trial Profile

A PHASE 1, OPEN-LABEL, RANDOMIZED, CROSSOVER, SINGLE DOSE STUDY TO DETERMINE THE BIOEQUIVALENCE OF 12.2 MG TAFAMIDIS FREE ACID TABLETS AND COMMERCIAL 20 MG TAFAMIDIS MEGLUMINE CAPSULES ADMINISTERED UNDER FASTED CONDITIONS AND THE EFFECT OF FOOD ON ORAL BIOAVAILABILITY OF 12.2 MG TAFAMIDIS FREE ACID TABLETS IN HEALTHY ADULT PARTICIPANTS

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 Jun 2024

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At a glance

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

Most Recent Events

  • 09 Jan 2023 Status changed from active, no longer recruiting to completed.
  • 05 Dec 2022 Planned End Date changed from 19 Dec 2022 to 11 Dec 2022.
  • 05 Dec 2022 Planned primary completion date changed from 19 Dec 2022 to 11 Dec 2022.

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