NCT06911567

A Study to Assess New Formulations of TEV-56286

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	TEV-56286 Test	Administered orally
DRUG	TEV-56286 Reference	Administered orally

Timeline

• Start date: 2025-03-10
• Primary completion: 2025-05-22
• Completion: 2025-06-02
• First posted: 2025-04-04
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study