Lesinurad/Allopurinol 200/300 FDC Tablets Bioequivalence
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 6/17/2017 |
| Start Date: | August 30, 2016 |
| End Date: | February 1, 2017 |
A Phase 1, Randomized, Open-Label, Replicate, Crossover Study to Assess the Bioequivalence of Lesinurad/Allopurinol Fixed-Dose Combination Tablets and Coadministered Lesinurad and Allopurinol Tablets in Fed Healthy Adult Subjects
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
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.
coadministered lesinurad and allopurinol tablets in the fed state.
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
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