Trials / Completed
CompletedNCT06705569
A Study to Compare Two Forms of Study Medicine Tafamidis in the Blood in Healthy Adults
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
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this clinical trial is to compare the amount of tafamidis in the blood of healthy adult participants after taking two different forms of tafamidis by mouth.
Detailed description
A new tafamidis free acid tablet is being developed to be bioequivalent to the current commercial 61 mg tafamidis free acid capsule. The purpose of the study is to establish the bioequivalence of 61 mg tafamidis free acid tablet (Test) to 61 mg tafamidis free acid capsule (Reference, the clinical supply form of the current commercial 61 mg tafamidis free acid capsule) administered under fasted conditions in healthy adult participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tafamidis 61 mg free acid tablet (Test) | Tafamidis 61 mg free acid tablet (Test) |
| DRUG | Tafamidis 61 mg free acid capsule (Reference) | Tafamidis 61 mg free acid capsule (Reference) |
Timeline
- Start date
- 2024-12-20
- Primary completion
- 2025-04-04
- Completion
- 2025-04-04
- First posted
- 2024-11-26
- Last updated
- 2025-05-28
Locations
1 site across 1 country: Belgium
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06705569. Inclusion in this directory is not an endorsement.