Lesinurad/Allopurinol 200/300 FDC Tablets Bioequivalence

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT02888054

Run by

Ardea Biosciences, Inc.

People needed

28

Starts

2016-08-30

Expected to finish

2017-02-01

Last updated by the study team

2017-06-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject has a body mass index ranging between 18 kg/m2 and 30 kg/m2.
• Screening serum urate level is ≤ 7.0 mg/dL.

You may not qualify if…

• 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

Where it is running

• Study site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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