drugset
drugset / Trial / NCT04811573

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

NCT04811573 ↗

Phase 1 Terminated 20 enrolled Boehringer Ingelheim
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2021-03-31
Primary completion
2021-08-18
Completion
2021-08-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Apremilast Small molecule 30 mg —

Indications

No indication recorded.