NCT04811573

A Study in Healthy People to Compare 3 Different Formulations of Apremilast Tablets Taken With or Without Food

Bioequivalence of Three Different Tablet Formulations of 30 mg of Apremilast (EU-sourced Otezla® vs. US-sourced Otezla® vs. Japan-sourced Otezla®) Administered in Healthy Male and Female Subjects in the Fasted State as Well as (for EU-sourced Otezla® vs. US-sourced Otezla®) in the Fed State (an Open-label, Randomised, Single-dose, Five-period, Ten-sequence Crossover Study)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The aim of this trial is to establish bioequivalence between EU-, US- and Japan-sourced Otezla® tablet formulations to assure comparability of results from Phase III trials of BI 730357 (new oral agent for treatment of psoriasis as well as other T helper 17 cells (Th17)-mediated diseases) regardless of whether only the EU-sourced Otezla® or EU and US-sourced Otezla®/Japan-sourced Otezla® have been used as an active comparator.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	EU-sourced Otezla®	Test product
DRUG	US-sourced Otezla®	Reference product 1
DRUG	Japan-sourced Otezla®	Reference product 2

Timeline

• Start date: 2021-03-31
• Primary completion: 2021-08-18
• Completion: 2021-08-18
• First posted: 2021-03-23
• Last updated: 2023-08-31
• Results posted: 2023-08-31

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study