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Status unknownNCT04157959Updated Nov 8, 2019

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

A Phase 1 interventional study of SHR4640 dose1 and Febuxostat dose2 in Hyperuricemia, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-11-08.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Hyperuricemia

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03

In context

Hyperuricemia

215 studies on the registry are indexed under Hyperuricemia; 40 are open to participants now.

This study's planned enrollment of 28 is below the median of 64 across 172 interventional studies indexed under Hyperuricemia.

Browse Hyperuricemia studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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。
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    SHR4640

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

    Drug: SHR4640 dose1 · Drug: Febuxostat dose2

  • Experimental
    Febuxostat

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

    Drug: SHR4640 dose1 · Drug: Febuxostat dose2

Interventions

  • DrugSHR4640 dose1

    Tablet,dose1,QD

  • DrugFebuxostat dose2

    Tablet,dose2,QD

06

What researchers measure

Primary outcomes

  1. Peak Plasma Concentration (Cmax) of SHR4640 and Febuxostat from plasma

    Time frame: Day1 to Day 14

  2. Area under the plasma concentration versus time curve (AUC) of SHR4640 and Febuxostat from plasma

    Time frame: Day1 to Day 14

Secondary outcomes

  1. Apparent terminal half-life (t1/2) of SHR4640 and Febuxostat from plasma

    Time frame: Day1 to Day 14

  2. Number of Participants With Adverse Events (AEs) and Serious Adverse Events

    Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination,vital signs, adverse events (NCI-CTC AE 5.0), etc.

    Time frame: Clinical significant changes from Day-21 up to Day 29

07

Study locations

1 of 1 sites recruiting
  • The Affiliated Hospital of QingDao University
    Qingdao, Shan Dong, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04157959
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Nov 8, 2019
Start date
Oct 14, 2019
Primary completion
Jun 1, 2020 (estimated)
Completion
Jun 30, 2020 (estimated)
Last update
Nov 8, 2019

Study contacts

Cao Yu
Contact
Caoyu1767@126.com
0532-82911767

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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