Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT06911567
Status:
COMPLETED
Last Update Posted:
2025-07-16
First Post:
2025-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess New Formulations of TEV-56286
Sponsor:
Teva Branded Pharmaceutical Products R&D LLC
Organization:
Study Overview
Official Title:
An Open-Label, Randomized, Crossover Study to Assess the Comparative Bioavailability of New TEV-56286 Formulations Compared to a Reference TEV-56286 Capsule Formulation Following Single-Dose Administration in Healthy Participants
Status:
COMPLETED
Status Verified Date:
2025-07
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 primary objective of the study is to assess the relative bioavailability of TEV-56286 test formulations compared to TEV-56286 reference product in healthy adult participants.
The secondary objective is to evaluate the safety and tolerability of TEV-56286.
The planned duration for each participant is approximately 70 days which includes a 45 day screening period.
The secondary objective is to evaluate the safety and tolerability of TEV-56286.
The planned duration for each participant is approximately 70 days which includes a 45 day screening period.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: