Diabetes Mellitus
Conditions
Brief summary
The study is being conducted to compare the pharmacokinetics and safety of HRS-7535 in subjects with mild to moderate hepatic impairment and normal hepatic function.
Interventions
DRUGHRS-7535 Tables
Oral HRS-7535 tables.
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Ability to understand the study procedures and methods, participate voluntarily and be able to complete the study according to the protocol requirements, and sign the informed consent form (ICF) in writing. 2. Aged 18-70 years old on the date of signing the ICF (including the threshold), both male and female. 3. At the time of screening, male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg; body mass index (BMI): 18\~32 kg/m2 (including the threshold).
Exclusion criteria
1. In the judgment of the investigator, may be allergic to the study drug or its components. 2. Smoking an average of more than 10 cigarettes per day within 3 months prior to screening. 3. Alcoholics of within 3 months prior to screening, who consume more than 14 units of alcohol per week (1 unit=beer)360 mL of alcohol, or 45 mL of strong liquor with an alcohol content of 40%, or 150 mL of wine. 4. History of drug or substance abuse, or a positive urine drug test at screening. 5. Donated or lost ≥ 400 mL of blood within 3 months prior to screening. 6. Individuals with a history of severe hypoglycemia. 7. Undergone surgery within 6 months prior to screening, or plan to undergo surgery during the trial period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The maximum plasma concentration of HRS-7535 (Cmax) | Post-dose at day 1 to day 4. |
| Area under the concentration curve from time 0 to the last quantifiable concentration (AUC0-t) | Post-dose at day 1 to day 4. |
| Area under the concentration curve from time 0 to extrapolated infinite time (AUC0-inf) | Post-dose at day 1 to day 4. |
Secondary
| Measure | Time frame |
|---|---|
| Time to maximum plasma concentration (Tmax) | Post-dose at day 1 to day 4. |
| Terminal half-life (t1/2) | Post-dose at day 1 to day 4. |
| Apparent clearance (CL/F) | Post-dose at day 1 to day 4. |
| Apparent volume of distribution (Vz/F) | Post-dose at day 1 to day 4. |
| Adverse events (AEs) | Screening period up to Day 7. |
Countries
China
Outcome results
None listed