Trials / Not Yet Recruiting
Not Yet RecruitingNCT07470866
A Study to Compare the Amount of Two Forms of Tafamidis in the Blood of Healthy Adults Under Fed Conditions
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 FED CONDITIONS IN HEALTHY ADULT PARTICIPANTS
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- 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 under fed conditions.
Detailed description
This study will be a Phase 1, open-label, randomized, two-treatment, two-period, crossover, single dose bioequivalence study to compare 61 mg tafamidis free acid tablet (Test) to 61 mg tafamidis free acid capsule (Reference) administered under fed conditions in healthy adult participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tafamidis (Reference) | 61 milligrams (mg) free acid capsule |
| DRUG | Tafamidis (Test) | 61 mg free acid tablet |
Timeline
- Start date
- 2026-03-27
- Primary completion
- 2026-06-06
- Completion
- 2026-06-06
- First posted
- 2026-03-13
- Last updated
- 2026-03-19
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07470866. Inclusion in this directory is not an endorsement.