The Drug-Drug Interaction of SHR4640 and Febuxostat in Patients With Hyperuricemia

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-14

Study Completion Date

2020-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Hyperuricemia

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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SHR4640

SHR4640 dose1 Oral Tablet Day1\~Day14 qd,Febuxostat dose2 Oral Tablet Day8 and Day14 qd.

Group Type EXPERIMENTAL

SHR4640 dose1

Intervention Type DRUG

Tablet,dose1,QD

Febuxostat dose2

Intervention Type DRUG

Tablet,dose2,QD

Febuxostat

Febuxostat dose2 Oral Tablet Day1 and Day14 qd, SHR4640 dose1 Oral Tablet Day8\~Day14 qd.

Group Type EXPERIMENTAL

SHR4640 dose1

Intervention Type DRUG

Tablet,dose1,QD

Febuxostat dose2

Intervention Type DRUG

Tablet,dose2,QD

Interventions

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SHR4640 dose1

Tablet,dose1,QD

Intervention Type DRUG

Febuxostat dose2

Tablet,dose2,QD

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subject has a body mass index ≥18 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. ALT、AST、TBIL\>ULN;
3. History of kidney stones or screening kidney stones by B-ultrasound；
4. History of malignancy；
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

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No