Healthy participants
Conditions
Interventions
Group 2:rosuvastatin calcium, digoxin tablets, XW003
Group1:metformin hydrochloride. warfarin, XW003
Sponsors
West China Second University Hospital of Sichuan University (WCSUH- SCU)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Male or non-pregnant and non-lactating female, aged 18 to 45 years (inclusive) at the time of providing informed consent. 2.Body Mass Index (BMI) between 20.0 and 30.0 kg/m^2 (inclusive) and body weight not less than 50.0 kg; 3.Subjects do not plan to conceive or donate sperm/oocytes from the start of the trial until 3 months after the last dose and voluntarily agree to use highly effective, medically accepted non-pharmacologic contraceptive methods (e.g., condoms, complete abstinence, intrauterine device [IUD], or surgical sterilization) throughout this period. 4.Subjects are able to communicate effectively with the investigator, understand the study requirements, and are willing and able to comply with all protocol requirements.
Exclusion criteria
Exclusion criteria: 1.Subjects with clinically significant diseases identified during screening (including, but not limited to, diseases related to the respiratory, circulatory, cardiovascular, digestive, hematological, endocrine, immune, dermatological, neuropsychiatric systems, or ENT disorders). 2.Subjects with a history of specific allergies (e.g., asthma, urticaria, eczema, allergy to glucagon-like peptide-1 [GLP-1] analogues or excipients), or those with allergic constitution (e.g., allergy to two or more drugs or substances such as milk or pollen), or known allergy to digoxin, warfarin, rosuvastatin, metformin, or any component of the investigational product. 3.Subjects with a history of dysphagia or any gastrointestinal disease that may affect drug absorption. 4.Subjects with any condition that increases the risk of bleeding, such as acute gastritis, gastric or duodenal ulcers, or acute hemorrhoidal episode within the past 3 months. 5.Subjects who have undergone major surgery within 6 months prior to screening or plan to undergo surgery during the study period. 6.Subjects with a history of surgery that could affect drug absorption, distribution, metabolism, or excretion. 7.Subjects judged by the clinician as having clinically significant abnormalities based on screening assessments including physical examination, electrocardiogram (ECG), vital signs, and laboratory tests (complete blood count [CBC], coagulation profile, blood biochemistry, thyroid function, calcitonin, urinalysis), specifically: (1) Screening 12-lead ECG showing QTc >= 450 ms for males or >= 460 ms for females. (2) Screening triglycerides >= 500 mg/dL (5.65 mmol/L). (3) Screening calcitonin >= 20 ng/L (pg/mL). (4) Screening renal dysfunction, defined as estimated glomerular filtration rate (eGFR) = 6.5%. (6) Any other abnormality judged by the clinician to be clinically significant. 8.Subjects testing positive for Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (anti-HCV), Anti-human immunodeficiency virus antibody (anti-HIV), or Treponema pallidum antibody / non-treponemal antigen (TP-TRUST). 9.Subjects with a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 syndrome (MEN2). 10.Subjects with a history of acute or chronic pancreatitis. 11.Subjects with a history of or suspected hypoglycemic episodes within 6 months prior to screening. 12.Subjects who regularly consumed alcohol within 6 months prior to screening (defined as > 2 units of alcohol per week, where one unit equals 360 mL beer [5% alcohol], 45 mL spirits [40% alcohol], or 150 mL wine [12% alcohol]) and/or who are unwilling to abstain from alcohol for 48 hours prior to and during the in-house study period (or test positive on alcohol breath test at admission). 13.Subjects with a history of illicit drug use, drug abuse within 6 months prior to screening, or a positive urine drug screen. 14.Subjects who smoke heavily (average > 5 cigarettes per day within 3 months prior to screening) and/or are unwilling to abstain from all tobacco products during the in-house study period. 15.Subjects with special dietary requirements who cannot comply with a standardized diet. 16.Subjects with a history of needle or blood phobia, difficulty with blood sampling, or inability to tolerate venipuncture. 17.Subjects with abnormal skin conditions (e.g., lesions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessment; | — |
Countries
China
Contacts
Public ContactYU Qin
West China Second University Hospital of Sichuan University (WCSUH- SCU)
Outcome results
None listed