Status:
COMPLETED
Lesinurad/Allopurinol 200/300 Fixed-Dose Combination (FDC) Tablets Bioequivalence.
Lead Sponsor:
Ardea Biosciences, Inc.
Conditions:
Gout
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- Body mass index ranging between 18.5 kg/m2 and 30 kg/m2.
- Screening serum urate level is ≤ 7.0 mg/dL.
Exclusion
- 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.
Key Trial Info
Start Date :
August 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2017
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03272425
Start Date
August 14 2017
End Date
October 4 2017
Last Update
November 7 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CAEP - Centro Avançado de Estudos e Pesquisas Ltda.
Campinas, São Paulo, Brazil