Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
Study NCT ID:
NCT07470866
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Compare the Amount of Two Forms of Tafamidis in the Blood of Healthy Adults Under Fed Conditions
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2026-525342-29-00 | REGISTRY | CTIS (EU) | View |