---
title: The Drug-Drug Interaction of SHR4640, Febuxostat and Colchicine in Patients With Gout
nct_id: NCT03131583
overall_status: COMPLETED
phase: PHASE1
sponsor: Jiangsu HengRui Medicine Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Gout
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03131583.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03131583"
ct_last_update_post_date: 2019-08-08
last_seen_at: "2026-05-12T07:05:44.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Drug-Drug Interaction of SHR4640, Febuxostat and Colchicine in Patients With Gout

**Official Title:** A Phase I, Single-Center, Open-Label, Single-Group Study to Evaluate Potential Pharmacodynamics of Drug-Drug Interaction Between SHR4640 and Febuxostat and Between SHR4640 and Colchicine in Patients With Gout

**NCT ID:** [NCT03131583](https://clinicaltrials.gov/study/NCT03131583)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 15
- **Lead Sponsor:** Jiangsu HengRui Medicine Co., Ltd.
- **Conditions:** Gout
- **Start Date:** 2017-02-17
- **Completion Date:** 2018-01-29
- **CT.gov Last Update:** 2019-08-08

## Brief Summary

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

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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。
```

## Arms

- **Cohort 1** (EXPERIMENTAL) — 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.

## Interventions

- **Colchicine** (DRUG) — Day-14\~Day16 qd
- **Febuxostat** (DRUG) — Day1 and Day8 qd
- **SHR4640** (DRUG) — Day3\~Day8 qd

## Primary Outcomes

- **Maximun observed concentration (Cmax) of Febuxostat and Colchicine from plasma** _(time frame: Clinical significant changes from baseline up to Day 8)_ — PK profile
- **Area under the concentration-time curve (AUC) of Febuxostat and Colchicine from plasma** _(time frame: Clinical significant changes from baseline up to Day 8)_ — PK profile
- **Apparent terminal half-life (t1/2) of Febuxostat and Colchicine from plasma** _(time frame: Clinical significant changes from baseline up to Day 8)_ — PK profile

## Secondary Outcomes

- **Incidence of Adverse events** _(time frame: Clinical significant changes from Day-14 up to Day 16)_
- **Changes in Laboratory Values** _(time frame: Clinical significant changes from Day-14 up to Day 16)_
- **Changes in Electrocardiogram** _(time frame: Clinical significant changes from Day-14 up to Day 16)_
- **Changes in Vital Signs Parameters** _(time frame: Clinical significant changes from Day-14 up to Day 16)_

## Locations (1)

- The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the first affiliated hospital of soochow university|suzhou|jiangsu|china` — added _(2026-05-12)_

---

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