Lesinurad/Allopurinol 200/300 FDC Tablets Bioequivalence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-30

Study Completion Date

2017-02-01

Brief Summary

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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

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Detailed Description

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The study will assess the BE between lesinurad/allopurinol 200/300 FDC tablets and coadministered lesinurad and allopurinol tablets in the fed state.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence ABBA

Day 1: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 8: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 15: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 22: lesinurad/allopurinol 200/300 FDC tablet (Sequence A)

Group Type EXPERIMENTAL

lesinurad/allopurinol 200/300 FDC tablet

Intervention Type DRUG

lesinurad 200 mg

Intervention Type DRUG

allopurinol 300 mg

Intervention Type DRUG

Sequence BABA

Day 1: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 8: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 15: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 22: lesinurad/allopurinol 200/300 FDC tablet (Sequence A)

Group Type EXPERIMENTAL

lesinurad/allopurinol 200/300 FDC tablet

Intervention Type DRUG

lesinurad 200 mg

Intervention Type DRUG

allopurinol 300 mg

Intervention Type DRUG

Sequence ABAB

Day 1: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 8: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 15: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 22: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B)

Group Type EXPERIMENTAL

lesinurad/allopurinol 200/300 FDC tablet

Intervention Type DRUG

lesinurad 200 mg

Intervention Type DRUG

allopurinol 300 mg

Intervention Type DRUG

Sequence BAAB

Day 1: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 8: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 15: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 22: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B)

Group Type EXPERIMENTAL

lesinurad/allopurinol 200/300 FDC tablet

Intervention Type DRUG

lesinurad 200 mg

Intervention Type DRUG

allopurinol 300 mg

Intervention Type DRUG

Interventions

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lesinurad/allopurinol 200/300 FDC tablet

Intervention Type DRUG

lesinurad 200 mg

Intervention Type DRUG

allopurinol 300 mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes