Lesinurad/Allopurinol 200/300 FDC Tablets Bioequivalence

Ardea Biosciences, Inc.28 enrolled

Overview

This study will assess the bioequivalence (BE) of Lesinurad/Allopurinol Fixed-Dose Combination (FDC) Tablets and Coadministered Lesinurad and Allopurinol Tablets in Fed Healthy Adult Subjects

The study will assess the BE between lesinurad/allopurinol 200/300 FDC tablets and coadministered lesinurad and allopurinol tablets in the fed state.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

lesinurad/allopurinol 200/300 FDC tabletDRUG

lesinurad 200 mgDRUG

allopurinol 300 mgDRUG

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Subject has a body mass index ranging between 18 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 suspicion of kidney stones. * Estimated creatinine clearance, as determined at Screening, of \< 90 mL/min calculated by the Cockcroft-Gault formula using ideal body weight. * Undergone major surgery within 3 months prior to Screening. * Donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1or 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)

Unnamed facility

Austin, Texas, United States

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 coadministered monocomponent tablets

Cmax is the maximum observed concentration of a drug after administration

Time frame: Days 1, 8, 15, and 22

PK endpoints in terms of time of occurrence of maximum observed concentration (tmax) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol coadministered monocomponent tablets

Tmax is the time of occurrence of cmax

Time frame: Days 1, 8, 15, and 22

PK endpoints in terms of area under plasma concentration time curve from zero to the last quantifiable sampling timepoint (AUC last) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol coadministered monocomponent tablets

AUC last is a measure of total plasma concentration from time zero to the last measurable concentration

Time frame: Days 1, 8, 15, and 22

PK endpoints in terms of area under the plasma concentration time curve from and from zero to infinity (AUC 0-∞) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol coadministered monocomponent tablets

AUC 0-∞ is a measure of total concentration from time zero to infinity

Time frame: Days 1, 8, 15, and 22

PK endpoints in terms of apparent terminal half-life (t1/2) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol coadministered monocomponent tablets

t1/2 is a measure of apparent terminal half-life

Time frame: Days 1, 8, 15, 22

Secondary Outcomes

Incidence of Adverse Events in terms of changes in laboratory parameters

Data from ClinicalTrials.gov

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