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

• Status: Completed
• Trial end date: 2017-10-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ardea Biosciences, Inc.
• Treatments: Allopurinol; Lesinurad

Criteria

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.