drugset / Trial / NCT04550234

A Study in Healthy Subjects to Assess Drug Availability of 4 Different Formulations of Verinurad and Allopurinol

NCT04550234

Phase 1 Completed 25 enrolled AstraZeneca Parexel · collab
RandomizedCrossoverOpen-labelTreatment

Summary

This study is a single centre, randomised, open-label, single-dose, 5-period, 5-treatment, crossover study in healthy male and female subjects. This study is intended to assess the relative bioavailability between the fixed dose combination (FDC, i.e. verinurad/allopurinol FDC capsule 12/300 mg) and free combination formulations of verinurad (i.e. verinurad prolonged release Hydroxypropyl methylcellulose \[HPMC\] capsule 12 mg) and allopurinol (i.e. allopurinol table 300 mg) in fasted and fed conditions. The study will also assess the relative bioavailability between a formulation only containing verinurad (i.e. verinurad prolonged release gelatin capsule 12 mg) and the FDC capsule.

Timeline

Start
2021-04-13
Primary completion
2021-07-15
Completion
2021-07-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Allopurinol Small molecule 300 mg Oral
Subject Verinurad Small molecule 12 mg Oral