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NCT04575116 · ClinicalTrials.gov registry record · Phase 1

A Study to Determine the Bioequivalence of Two Doses of Tafamidis

A Phase 1 study, sponsored by Pfizer.

Completed
Registry status
Phase 1
Development phase
23
Enrollment target

NCT04575116: Completed Phase 1 study, sponsored by Pfizer.

NCT04575116 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04575116, a Phase 1 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 1
Development phase
23 participants
Enrollment target

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.

Primary Outcome

Area under the plasma concentration time profile from time zero extrapolated to infinite time

Interventions

  • DRUG Tafamidis free acid tablet
  • DRUG Tafamidis meglumine capsule

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2020-09-17
Est. Completion 2021-02-23
Phase Phase 1
Pfizer

1,845 total trials

What the finished NCT04575116 record still lists

NCT04575116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 2 interventions - of which Tafamidis free acid tablet is the first listed.

NCT04575116 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04575116 about?

NCT04575116 is a clinical study titled "A Study to Determine the Bioequivalence of Two Doses of Tafamidis". 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.

What is the current status of trial NCT04575116?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2020-09-17. Estimated completion is 2021-02-23.

What interventions are being tested in trial NCT04575116?

The interventions under investigation include: Tafamidis free acid tablet (DRUG), Tafamidis meglumine capsule (DRUG).

Who is sponsoring clinical trial NCT04575116?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04575116's enrollment target sits among peer trials

23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04575116, the US trial registry maintained by the National Library of Medicine. NCT04575116 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.