Lesinurad/Allopurinol 200/300 FDC Tablets Bioavailability
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/14/2017 |
| Start Date: | October 2015 |
| End Date: | August 2016 |
A Phase 1, Randomized, Open-Label, Crossover Study to Assess the Relative Bioavailability of Lesinurad/Allopurinol Fixed Dose Combination Tablets and Coadministered Lesinurad and Allopurinol Tablets and the Effect of Food on the Pharmacokinetics of Lesinurad/Allopurinol Fixed Dose Combination Tablets in Healthy Adult Male Subjects
This study will assess relative bioavailability of lesinurad/allopurinol fixed dose
combination (FDC), its individual components and the effect of food.
combination (FDC), its individual components and the effect of food.
The study comprises 2 parts. Part 1 will assess the relative BA of lesinurad/allopurinol FDC
and monocomponents in fasted subjects. Part 2 will assess the effect of food on the PK of FDC
tablets.
and monocomponents in fasted subjects. Part 2 will assess the effect of food on the PK of FDC
tablets.
Inclusion Criteria:
- Body mass index ranging between 18 kg/m2 and 40 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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