Trials / Completed
CompletedNCT01986556
Lesinurad Tablet Relative Bioavailability
A Phase 1, Randomized, Open-Label, Crossover Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability of Lesinurad Tablets Manufactured at Two Different Sites
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Ardea Biosciences, Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
This study will assess the relative bioavailability of lesinurad tablets, manufactured at two different sites.
Detailed description
A change in manufacturing site of lesinurad tablets has been implemented. This study is intended to evaluate the clinical comparability of lesinurad tablets manufactured at the two different sites by assessing relevant clinical Pharmacokinetics (PK) parameters.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lesinurad 400 mg (Site 1) | |
| DRUG | Lesinurad 400 mg (Site 2, Lot A) | |
| DRUG | Lesinurad 400 mg (Site 2, Lot B) |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2014-04-01
- Completion
- 2014-05-01
- First posted
- 2013-11-18
- Last updated
- 2014-09-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01986556. Inclusion in this directory is not an endorsement.