Healthy Chinese Participants
Conditions
Interventions
High fat meal AB group:In the morning, the first group (AB) of subjects took the study drug HS-10380 tablets 1.5mg orally on an empty stomach.
High fat meal BA group:The second group (BA group) of subjects took orally the study drug HS-10380 tablets, 1.5mg, 30 minutes after starting their meal (timing from the first bite).
Low fat meal AB group:In the morning, the first group (AB) of subjects took the study drug HS-10380 tablets 1.5mg orally on an empty stomach.
Low fat meal BA group:The second group (BA group) of subjects took orally the study drug HS-10380 tablets, 1.5mg, 30 minutes after starting their meal (timing from the first bite).
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: All subjects must meet all of the following inclusion criteria: 1) Sign an informed consent form before the experiment, fully understand the content, process, and potential adverse reactions of the experiment, and self report being able to complete the research in accordance with the research regulations; 2) Adult male and female subjects (aged = 18 years old, calculated on the day of signing the informed consent form); 3) The subject's body mass index (BMI)=weight (kg)/height 2 (m2), with a body mass index ranging from 18.0 to 26.0kg/m2 (including critical values). Male subjects weighing = 50kg, female subjects weighing = 45kg; 4) Men or women who agree to effective contraception within 6 months after signing the informed consent form and have no plans to conceive, donate sperm or eggs during this period (only non pharmacological contraception measures can be used during the study period).
Exclusion criteria
Exclusion criteria: All subjects are not eligible for inclusion if they meet any of the following exclusion criteria: 1) Physical examination, vital sign examination, electrocardiogram, clinical laboratory examination, etc., which have been judged abnormal by the researcher and have clinical significance; 2) During the screening period, those who are positive for any one or more of hepatitis B virus surface antigen, hepatitis C virus antibody, Treponema pallidum antibody, or human immunodeficiency virus antibody; 3) During the screening period, ALT, AST, creatinine, and urea nitrogen exceeded the normal upper limit, and were judged abnormal by the researcher and clinically significant; 4) During the screening period, serum prolactin is greater than twice the normal upper limit, and has been judged abnormal by the researcher and has clinical significance; 5) Patients with prolonged QT interval (male QTcF = 450ms; female QTcF = 470ms) according to the results of 12-lead electrocardiogram examination during the screening period; 6) Individuals who have previously suffered from serious diseases such as the nervous system, mental system, digestive system, circulatory system, respiratory system, and urinary system, or have existing or newly developed diseases before the use of the study drug, and have been evaluated by the researcher as not suitable to participate in this experimental study; 7) Individuals with a history of orthostatic hypotension; 8) Individuals with a history of increased QT interval prolongation (such as heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, etc.); 9) Individuals with a history of gastrointestinal diseases such as gastric ulcer and reflux esophagitis; 10) Those who have undergone surgeries that may affect drug absorption, distribution, metabolism, and excretion, but have been judged by the researchers to be unsuitable for enrollment; 11) Individuals who are prone to allergic reactions or allergic constitution (such as those who are allergic to pollen, two or more drugs/foods), or those who are known to be allergic to the components of this drug; 12) Those who have participated in any other clinical trial and used the investigational drug within 3 months prior to screening; 13) Individuals who donate blood or experience significant blood loss (>400mL) within the first 3 months of screening, or those who plan to donate blood from the study period to 1 month after completion of the study; 14) Those who consume grapefruit or grapefruit products within 48 hours before the first administration of the study drug; 15) Individuals who consume excessive amounts of tea, coffee, and or caffeinated beverages within the first three months of screening (with an average of 8 or more cups per day and 1 cup=200mL); 16) Individuals who smoke an average of more than 5 cigarettes per day within the first 3 months of screening, or who cannot stop using any tobacco products during the trial period; 17) Those who regularly drink alcohol within 3 months before screening (that is, those who drink more than 14 units of alcohol per week, 1 unit=14g alcohol, equivalent to 360mL beer or 45mL spirits or 150mL wine with 40% alcohol, equivalent to 10 bottles of beer or 1 jin of Baijiu or 3 bottles of red wine per week) or those who cannot stop drinking alcohol products during the test; 18) Those who have consumed any alcoholic products within 24 hours before taking the study medication, or th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactLi Zheng
West China Hospital of Sichuan University
Outcome results
None listed