A study to assess the relative bioavailability of 3 different formulations under fasted and fed condition

Study identifier:D5495C00005

ClinicalTrials.gov identifier:NCT04024501

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomised, Single-dose, 5-period, 5-treatment, Crossover Study to Assess the Relative Bioavailability of 3 Different Extended-release Formulations of Verinurad in Healthy Subjects

Medical condition

Chronic Kidney Disease

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Verinurad ER8 capsule formulation (fasted), Verinurad A-capsule formulation (fasted), Verinurad A-capsule formulation (fed), Verinurad B-capsule formulation (fasted), Verinurad B-capsule formulation (fed)

Sex

All

Actual Enrollment

25

Study type

Interventional

Age

18 Years - 50 Years

Date

Study Start Date: 20 Jul 2019
Primary Completion Date: 18 Sept 2019
Study Completion Date: 18 Sept 2019

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2021 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria