Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06273839
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2024-02-15
Brief Title:
A Study to Learn How Different Forms of Study Medicine Tafamidis Are Taken Up Into The Blood in Healthy Adults
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 1 OPEN-LABEL RANDOMIZED THREE-TREATMENT THREE-PERIOD CROSSOVER SINGLE DOSE STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF 61 MG AND 70 MG TAFAMIDIS FREE ACID TABLETS TO COMMERCIAL 61 MG TAFAMIDIS FREE ACID CAPSULE ADMINISTERED UNDER FASTED CONDITIONS IN HEALTHY ADULT PARTICIPANTS
Status:
COMPLETED
Status Verified Date:
2024-06
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 three 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 estimate the relative bioavailability of 61 mg tafamidis free acid tablet Test 1 and 70 mg tafamidis free acid tablet Test 2 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
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-509241-12-00 | REGISTRY | None | None |