Bioequivalence Study of 2 Sizes of SHR4640 Tablets Orally in Healthy Subjects

NCT06168929 | Completed Phase 1

• 1 other identifier: SHR4640-112
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the pharmacokinetic, and safety of two sizes of SHR4640 tablets in healthy adults, to explore the bioequivalence between two sizes of SHR4640 tablets.

Conditions

Hyperuricemia

Outcome Measures

Primary Outcomes (3)

• PK parameters of SHR4640: Cmax

  0 hour to 72 hour after administration

• PK parameters of SHR4640: AUC0-t

  0 hour to 72 hour after administration

• PK parameters of SHR4640: AUC0-inf

  0 hour to 72 hour after administration

Secondary Outcomes (5)

• PK parameters of SHR4640: Tmax

  0 hour to 72 hour after administration

• PK parameters of SHR4640: t1/2

  0 hour to 72 hour after administration

• PK parameters of SHR4640: CL/F

  0 hour to 72 hour after administration

• PK parameters of SHR4640: Vz/F

  0 hour to 72 hour after administration

• Adverse events

  from ICF signing date to approximate day 13

Study Arms (2)

Treatment group A

EXPERIMENTAL

Drug: SHR4640

Treatment group B

EXPERIMENTAL

Drug: SHR4640

Interventions

SHR4640 DRUG

SHR4640, 2.5mg\*4 - 10mg\*1

Treatment group A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able and willing to provide a written informed consent.
• years to 45 years (inclusive).
• Body weight should above 45 kg, and body mass index should be between 19 and 28 kg/m2 (inclusive).
• The physical examination, vital signs, laboratory examination and electrocardiogram are not abnormal or abnormal but with no clinical significance.

You may not qualify if:

• Pregnant or nursing women.
• No birth control 1 weeks before screening or until one week after SHR4640 administration.
• Average daily alcohol consume more than 14g for female or more than 28g for male within 1 month before screening, or baseline alcohol screening is positive.
• Smokers (average daily smoking of 5 cigarettes or more in the 3 months before screening).
• Subject with a history of substance abuse and drug abuse.
• The investigators determined that other conditions were inappropriate for participation in this clinical trial.
• sUA level ≥480 μmol/L.
• eGFR \< 90 mL/min/1.73 m2.
• Positive result for human immunodeficiency virus (HIV), hepatitis C virus antibody, or syphilis antibody, or hepatitis B surface antigen.
• lead electrocardiogram (ECG) showed abnormal and clinically significant.
• Cardiovascular, neuropsychiatric, respiratory, digestive tract, endocrine and other systemic diseases within 1 year before screening, which were judged to be serious by the investigators.
• History of hypersensitivity to SHR4640 or its analogues.
• History or suspected crystals or stones in the urinary system during the screening period of B-ultrasound.
• History of been diagnosed with acute kidney injury in the past or screening period.
• Had undergone major surgery within 3 months prior to screening, or have not recovered from surgery, or plan major surgery during the study.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Central Hospital Affilated to Shandong First Medical University

Jinan, Shandong, 250013, China

Location

MeSH Terms

Conditions

Hyperuricemia

Interventions

ruzinurad

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Open, Single Dose, Two Sequences, Two Cycles, Self-Crossover Control

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: December 13, 2023
• Primary Completion: January 13, 2024
• Study Completion: January 13, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

CN (1)