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

Overview

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

Full Title of Study: “A Phase I, Single-Center, Open-Label Study to Evaluate Pharmacodynamics of Drug-Drug Interaction Between SHR4640 and Febuxostat in Patients With Hyperuricemia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2020

Interventions

  • Drug: SHR4640 dose1
    • Tablet,dose1,QD
  • Drug: Febuxostat dose2
    • Tablet,dose2,QD

Arms, Groups and Cohorts

  • Experimental: SHR4640
    • SHR4640 dose1 Oral Tablet Day1~Day14 qd,Febuxostat dose2 Oral Tablet Day8 and Day14 qd.
  • Experimental: Febuxostat
    • Febuxostat dose2 Oral Tablet Day1 and Day14 qd, SHR4640 dose1 Oral Tablet Day8~Day14 qd.

Clinical Trial Outcome Measures

Primary Measures

  • Peak Plasma Concentration (Cmax) of SHR4640 and Febuxostat from plasma
    • Time Frame: Day1 to Day 14
  • Area under the plasma concentration versus time curve (AUC) of SHR4640 and Febuxostat from plasma
    • Time Frame: Day1 to Day 14

Secondary Measures

  • Apparent terminal half-life (t1/2) of SHR4640 and Febuxostat from plasma
    • Time Frame: Day1 to Day 14
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events
    • Time Frame: Clinical significant changes from Day-21 up to Day 29
    • Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination,vital signs, adverse events (NCI-CTC AE 5.0), etc.

Participating in This Clinical Trial

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。

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jiangsu HengRui Medicine Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Cao Yu, 0532-82911767, Caoyu1767@126.com

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