The Drug-Drug Interaction of SHR4640, 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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-17

Study Completion Date

2018-01-29

Brief Summary

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The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640, Febuxostat and Colchicine interaction in patients with gout.

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Detailed Description

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Conditions

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Gout

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Colchicine 0.5 mg Oral Tablet Day-14\~Day16 qd, Febuxostat 80 mg Oral Tablet Day1 and Day8 qd, SHR4640 10 mg Oral Tablet Day3\~Day8 qd.

Group Type EXPERIMENTAL

Colchicine

Intervention Type DRUG

Day-14\~Day16 qd

Febuxostat

Intervention Type DRUG

Day1 and Day8 qd

SHR4640

Intervention Type DRUG

Day3\~Day8 qd

Interventions

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Colchicine

Day-14\~Day16 qd

Intervention Type DRUG

Febuxostat

Day1 and Day8 qd

Intervention Type DRUG

SHR4640

Day3\~Day8 qd

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subject has a body mass index ≥18.5 and ≤30 kg/m2;
2. Screening sUA value ≥8mg/dl;
3. Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.

Exclusion Criteria

1. Subject known or suspected of being sensitive to the study drugs or its ingredient；
2. sCr\>ULN;
3. History of kidney stones or screening kidney stones by B-ultrasound；
4. History of malignancy within 5 years；
5. History of xanthinuria；
6. Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood。

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No