To Evaluate Drug Interactions Between XNW3009, Febuxostat, and Colchicine in Patients With Gout

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-18

Study Completion Date

2022-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A single-center, open-access study to evaluate drug interactions between XNW3009, febuxostat, and colchicine in patients with gout

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of Oral Febuxostat in Subjects With Gout

NCT02082769

Gout

COMPLETED PHASE3

Low-dose Colchicine With or Without Stepwise Dose Titration of Febuxostat for Flare Prophylaxis in Gout

NCT04697602

Gout

TERMINATED NA

The Drug-Drug Interaction of SHR4640, Febuxostat and Colchicine in Patients With Gout

NCT03131583

Gout

COMPLETED PHASE1

Study to Evaluate sUA-Lowering Activity, Safety & PK Interaction of Oral BCX4208 & Allopurinol Admin. in Subjects w/Gout

NCT01129648

Gout

COMPLETED PHASE2

Efficacy and Safety of Simiaowan in Prevention of Acute Flares in Chronic Gout Patients Initiating Febuxostat Therapy

NCT04069325

Gout Flare

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gout

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1

Colchicine 0.5 mg Oral Tablet Day-7\~Day25 qd, Febuxostat 40 mg Oral Tablet Day1 and Day14 qd, XNW3009 0.5 mg Oral Tablet Day8\~Day21 qd.

Interventions:

Drug: Colchicine Drug: Febuxostat Drug: XNW3009

Group Type OTHER

Colchicine

Intervention Type DRUG

Colchicine0.5 mg Oral Tablet Day-7\~Day25 qd；Febuxostat 40 mg Oral Tablet Day1 and Day14 qd；XNW3009 0.5 mg Oral Tablet Day8 and Day21 qd

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Colchicine

Colchicine0.5 mg Oral Tablet Day-7\~Day25 qd；Febuxostat 40 mg Oral Tablet Day1 and Day14 qd；XNW3009 0.5 mg Oral Tablet Day8 and Day21 qd

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Febuxostat、XNW3009

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subject has a body mass index ≥18.0 and ≤32 kg/m2;
* Screening sUA value ≥480μmol/L;
* Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.

Exclusion Criteria

* Subject known or suspected of being sensitive to the study drugs or its ingredient；sCr\>ULN；
* History of kidney stones or screening kidney stones by B-ultrasound;
* History of malignancy；
* History of xanthinuria；
* Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood
* ALT or AST \> 1.5 x ULN
* Unstable angina, history of symptomatic arrhythmia, or heart failure
* HbAlc\>8%
* eGFR\<60ml/min/1.73m2
* Investigational drug within 3 months of study dosing

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No