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Clinical Trial 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.


Clinical Trial Description

The study comprises of: - A Screening Period of maximum 28 days; - Five treatment periods during which subjects will be resident from the morning of Day -2 until at least 72 hours after dosing in Treatment Period 5; discharged on the morning of Day 4 of Treatment Period 5; and - A Follow-up Visit 7 to 14 days after the last dosing. Each subject will receive 5 single dose treatments of verinurad and allopurinol or verinurad alone and subject will be involved in the study for 52 to 59 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04550234
Study type Interventional
Source AstraZeneca
Contact
Status Completed
Phase Phase 1
Start date April 13, 2021
Completion date July 15, 2021

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