Bioequivalence of a Hydroxyurea Oral Suspension (100 mg/mL) and Xromi® 100 mg/mL Oral Solution (100 mg Hydroxycarbamide) under Fasting Conditions: A Randomised, Open-label, Single-dose, Two-period Crossover Study

Introduction

Hydroxyurea oral suspension is approved as an adjunctive treatment for Sickle Cell Disease (SCD) and Myeloproliferative Disorders (MPD). Oral liquid formulations ensure accurate dose administration, improve ease of use in patients with difficulty swallowing solid dosage forms, and may be administered with or without food. As patient-friendly formulations are increasingly needed, there is growing demand for a bioequivalent alternative to the marketed reference hydroxyurea oral solution.