Lesinurad/Allopurinol 200/300 Fixed-Dose Combination (FDC) Tablets Bioequivalence.

Ardea Biosciences, Inc.32 enrolled

Overview

To assess the bioequivalence between lesinurad/allopurinol 200/300 FDC tablets and coadministered lesinurad and allopurinol tablets in the fasted state based on the pharmacokinetic (PK) evaluation of lesinurad and allopurinol in healthy adult subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gout

Interventions

lesinurad/allopurinol 200/300 FDC tabletsDRUG

Test Drug

lesinurad 200 mgDRUG

Comparator 1

allopurinol 300 mgDRUG

Comparator 2

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Body mass index ranging between 18.5 kg/m2 and 30 kg/m2. * Screening serum urate level is ≤ 7.0 mg/dL. Exclusion Criteria: * Asian subject who has a positive test for the HLA-B\*5801 allele. * History or current diagnosis of kidney stones. * Estimated creatinine clearance, as determined at Screening, of ≤ 80 mL/min calculated by the Cockcroft-Gault formula using ideal body weight. * Undergone major surgery within 3 months prior to Screening. * Donated blood within 4 weeks prior to Day 1 or experienced an event (other than blood donation) of significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or has given a plasma donation within 4 weeks prior to Day 1. * Inadequate venous access or unsuitable veins for repeated venipuncture. * Received any strong or moderate enzyme-inducing drug or product within 2 months prior to Screening.

Locations (1)

CAEP - Centro Avançado de Estudos e Pesquisas Ltda.

Campinas, São Paulo, Brazil

Outcomes

Primary Outcomes

Pharmacokinetics (PK) endpoints in terms of maximum observed concentration (Cmax) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol monocomponent tablets

Cmax is the maximum observed concentration of a drug after administration