Study on the Bioavailability of Three Different Prescription Processes of SHR4640 Tablets in Healthy Volunteers

NCT ID: NCT04586803

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2020-12-31

Brief Summary

The primary objective of the study is to evaluate the relative bioavailability of three different prescription processes of SHR4640 tablets in healthy volunteers. The secondary objective of the study is to observe the safety of SHR4640 tablets in healthy subjects.

Detailed Description

Study Type: Interventional Enrollment: Number of Subjects: 24 Type: Anticipated

Allocation : Yes Intervention Model : Single center, randomized, open Intervention Model Description: 3 cycles, 6 sequences Masking: No Masking

Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet.

Conditions

Primary Gout; Hyperuricemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

A

Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet.

Group Type: EXPERIMENTAL

SHR4640

Intervention Type: DRUG

Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet.

B

Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet.

Group Type: EXPERIMENTAL

SHR4640

Intervention Type: DRUG

Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet.

C

Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet.

Group Type: EXPERIMENTAL

SHR4640

Intervention Type: DRUG

Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet.

D

Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet.

Group Type: EXPERIMENTAL

SHR4640

Intervention Type: DRUG

Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet.

E

Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet.

Group Type: EXPERIMENTAL

SHR4640

Intervention Type: DRUG

Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet.

F

Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet.

Group Type: EXPERIMENTAL

SHR4640

Intervention Type: DRUG

Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet.

Interventions

SHR4640

Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1) Voluntarily sign the informed consent form before the start of the activities related to this trial, and be able to understand the procedures and methods of this trial, and be willing to strictly abide by the clinical trial plan to complete this trial; 2) Aged between 18 and 45 years old (including both ends, whichever is the time of signing the informed consent form), male; 3) Body weight ≥ 50 kg, and body mass index (BMI): 19-26 kg/m2 (both ends included).

Exclusion Criteria

• Subjects will not be allowed to enter this study if they meet any of the following criteria:

1. General situation:

1. Have a fertility plan within 3 months after screening to the last medication, or refuse to use medically approved contraceptive methods;

2. Drug abusers or drug urine screening positive;

3. Smokers (average daily smoking 5 or more) or urine Nicotin positive.

4. The average daily alcohol intake during the first month was more than 25 g (for example, 750 mL beer, 250 mL wine or 50 mL low spirits);

5. Anyone who had eaten grapefruit or fruit juice products within 2 days before administration, any food or drink containing caffeine (such as coffee, tea, chocolate, cola or other caffeinated carbonated drinks, etc.) and foods or drinks rich in purine food or alcohol.

6. The researchers judged that the subjects had medical conditions that affected the absorption, distribution, metabolism and excretion of drugs or reduced compliance.

2. Laboratory tests showed the following conditions:

1. Those with sUA > 420 µmol / L during the screening period, or those with a previous history of hyperuricemia and / or gout;

2. Those with estimated glomerular filtration rate (eGFR) < 90 during the screening period;

3. Those with urolithiasis indicated or suspected by B ultrasound during the screening period;

4. Those who were positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody or syphilis antibody within one month or during the screening period.

3. There is any history of any of the following or concomitant diseases:

1. Any clinical history of serious illness or disease or condition that the researchers believe may affect the results of the trial, including, but not limited to, a history of circulatory, endocrine, nervous, digestive, urinary or hematological, immune, mental and metabolic diseases.

2. People with allergies, including those who are explicitly allergic to research drugs or any ingredient in research drugs, are allergic to any food ingredient or have special requirements for diet, and are unable to follow a uniform diet;

3. Screening those who have undergone any operation within the first 3 months, or who have not recovered after the operation, or who may have a plan for operation or hospitalization during the trial;

4. Those who donated blood (or lost blood) within the first 3 months and donated blood (or lost blood) more than 400 mL, or received blood transfusion.

4. Use any of the following drugs or participate in clinical trials:

1. Screen people who have participated in clinical trials of any drug or medical device within the previous 3 months;

2. Take any prescription drug, over-the-counter medicine, Chinese herbal medicine or dietary supplement within 2 weeks before the screening period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zourong Ruan, PhD

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Medical College of Zhejiang University

Central Contacts

Sheng Zhong, Master

Role: CONTACT

zhongsheng@hrglobe.cn

13564101315 ext. +86

Yuxiong Gao, PhD

Role: CONTACT

gaoyuxiong@hrglobe.cn

19821262236 ext. +86

Other Identifiers

SHR4640-Ⅰ-109

Identifier Type: -

Identifier Source: org_study_id