- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06168929
Bioequivalence Study of 2 Sizes of SHR4640 Tablets Orally in Healthy Subjects
January 21, 2024 updated by: Jiangsu HengRui Medicine Co., Ltd.
Bioequivalence Study of 2 Sizes of SHR4640 Tablets in Healthy Subjects (Randomized, Open, Single Dose, Two Sequences, Two Cycles, Self-Crossover Control)
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250013
- Central Hospital Affilated to Shandong First Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Able and willing to provide a written informed consent.
- 18 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.
Exclusion Criteria:
- 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.
- 12-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.
- Blood donation within 1 month before screening; Or patients with trauma or major surgical procedures who donated blood or lost blood > 400 mL in the 3 months prior to screening.
- Has unsuitable venous for blood sampling.
- Received the last dose of a study drug (or treatment with a medical device) within 3 months or 5 T1/2 (whichever is longer) of the screening or are currently participating in another study of a study drug (or medical device).
- Have received or been exposed to other live vaccines or live attenuated vaccines within 3 months prior to Day 1, or who plan to receive live vaccines or live attenuated vaccines during the study.
- Consumes grapefruit and/or poppy seed within 48 hours before SHR4640 administration.
- Taken any prescription drugs, over-the-counter drugs, herbal medicines or food supplements within 2 weeks before screening.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group A
|
SHR4640, 2.5mg*4 - 10mg*1
SHR4640, 10mg*1 - 2.5mg*4
|
Experimental: Treatment group B
|
SHR4640, 2.5mg*4 - 10mg*1
SHR4640, 10mg*1 - 2.5mg*4
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PK parameters of SHR4640: Cmax
Time Frame: 0 hour to 72 hour after administration
|
0 hour to 72 hour after administration
|
PK parameters of SHR4640: AUC0-t
Time Frame: 0 hour to 72 hour after administration
|
0 hour to 72 hour after administration
|
PK parameters of SHR4640: AUC0-inf
Time Frame: 0 hour to 72 hour after administration
|
0 hour to 72 hour after administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PK parameters of SHR4640: Tmax
Time Frame: 0 hour to 72 hour after administration
|
0 hour to 72 hour after administration
|
PK parameters of SHR4640: t1/2
Time Frame: 0 hour to 72 hour after administration
|
0 hour to 72 hour after administration
|
PK parameters of SHR4640: CL/F
Time Frame: 0 hour to 72 hour after administration
|
0 hour to 72 hour after administration
|
PK parameters of SHR4640: Vz/F
Time Frame: 0 hour to 72 hour after administration
|
0 hour to 72 hour after administration
|
Adverse events
Time Frame: from ICF signing date to approximate day 13
|
from ICF signing date to approximate day 13
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 13, 2023
Primary Completion (Actual)
January 13, 2024
Study Completion (Actual)
January 13, 2024
Study Registration Dates
First Submitted
December 5, 2023
First Submitted That Met QC Criteria
December 5, 2023
First Posted (Actual)
December 13, 2023
Study Record Updates
Last Update Posted (Actual)
January 23, 2024
Last Update Submitted That Met QC Criteria
January 21, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHR4640-112
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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