临床试验/NCT02888054

NCT02888054已完成1 期

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

Ardea Biosciences, Inc.0 个研究点目标入组 28 人开始时间: 2016年8月30日最近更新: 2017年6月16日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Ardea Biosciences, Inc.
入组人数: 28
主要终点: PK endpoints in terms of area under the plasma concentration time curve from and from zero to infinity (AUC 0-∞) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol coadministered monocomponent tablets

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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

详细描述

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

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Subject has a body mass index ranging between 18 kg/m2 and 30 kg/m
•Screening serum urate level is ≤ 7.0 mg/dL.

排除标准

•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
•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

研究组 & 干预措施

Sequence ABBA

Experimental

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)

干预措施: lesinurad/allopurinol 200/300 FDC tablet (Drug)

Sequence ABBA

Experimental

干预措施: lesinurad 200 mg (Drug)

Sequence ABBA

Experimental

干预措施: allopurinol 300 mg (Drug)

Sequence BABA

Experimental

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)

干预措施: lesinurad/allopurinol 200/300 FDC tablet (Drug)

Sequence BABA

Experimental

干预措施: lesinurad 200 mg (Drug)

Sequence BABA

Experimental

干预措施: allopurinol 300 mg (Drug)

Sequence ABAB

Experimental

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)

干预措施: lesinurad/allopurinol 200/300 FDC tablet (Drug)

Sequence ABAB

Experimental

干预措施: lesinurad 200 mg (Drug)

Sequence ABAB

Experimental

干预措施: allopurinol 300 mg (Drug)

Sequence BAAB

Experimental

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)

干预措施: lesinurad/allopurinol 200/300 FDC tablet (Drug)

Sequence BAAB

Experimental

干预措施: lesinurad 200 mg (Drug)

Sequence BAAB

Experimental

干预措施: allopurinol 300 mg (Drug)

结局指标

主要结局

PK endpoints in terms of area under the plasma concentration time curve from and from zero to infinity (AUC 0-∞) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol coadministered monocomponent tablets

时间窗: Days 1, 8, 15, and 22

AUC 0-∞ is a measure of total concentration from time zero to infinity

PK endpoints in terms of time of occurrence of maximum observed concentration (tmax) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol coadministered monocomponent tablets

时间窗: Days 1, 8, 15, and 22

Tmax is the time of occurrence of cmax

PK endpoints in terms of area under plasma concentration time curve from zero to the last quantifiable sampling timepoint (AUC last) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol coadministered monocomponent tablets

时间窗: Days 1, 8, 15, and 22

AUC last is a measure of total plasma concentration from time zero to the last measurable concentration

PK endpoints in terms of apparent terminal half-life (t1/2) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol coadministered monocomponent tablets

时间窗: Days 1, 8, 15, 22

t1/2 is a measure of apparent terminal half-life

Pharmacokinetics (PK) endpoints in terms of maximum observed concentration (Cmax) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol coadministered monocomponent tablets

时间窗: Days 1, 8, 15, and 22

Cmax is the maximum observed concentration of a drug after administration

次要结局

Incidence of Adverse Events in terms of electrocardiogram parameters(8 weeks)
Incidence of Adverse Events in terms of changes in laboratory parameters(8 weeks)
Incidence of Adverse Events in terms of vital signs(8 weeks)

研究者

发起方

Ardea Biosciences, Inc.

申办方类型

Industry

责任方

Sponsor

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