hyperlipoproteinemia
Conditions
Interventions
Sponsors
People's Hospital of Deyang City
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Chinese male or female subjects aged >=18 years and 50 kg, female >=45 kg, and body mass index (BMI) between 19.0 and 26.0 kg/m^2 (inclusive, BMI = weight (kg)/height² (m^2)); 3.At screening, the subject's vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, and chest X-ray results are normal or abnormal but judged by the investigator as clinically insignificant; 4.Subjects have no history or current evidence of the following diseases or conditions, or if present, are judged by the investigator as clinically insignificant, including but not limited to cardiovascular, digestive, urogenital, respiratory, hematological, endocrine, immune, neuropsychiatric, musculoskeletal systems, etc. particularly subjects with gastrointestinal dysfunction, peptic ulcers, gastrointestinal surgery, or other diseases that may affect drug absorption, distribution, metabolism, and excretion; 5.Subjects have no pregnancy plans from the signing of the informed consent form until 3 months after the last dose and voluntarily adopt effective non-pharmacological contraceptive measures to prevent pregnancy of the subject or their spouse, with no plans for sperm or egg donation; 6.Subjects understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Subjects with a history of myopathy, myalgia, muscle or tendon injuries, or predisposing factors for myopathy/rhabdomyolysis (e.g., personal or family history of hereditary muscle disorders, prior drug-induced myotoxicity); 2.Subjects with a history of liver disease or active liver disease, including unexplained persistent elevation of serum transaminases or any elevation of serum transaminases exceeding 50% of the upper limit of normal (ULN) or serum creatinine levels exceeding 10% of the ULN; 3.Subjects who have undergone surgery within 3 months prior to screening, plan to undergo surgery during the study or within 2 weeks after study completion, or have a history of surgery that may affect drug absorption, distribution, metabolism, or excretion; 4.Subjects with a history of clinically significant food or drug allergies (as determined by the investigator) known hypersensitivity to rosuvastatin calcium tablets or their excipients or other allergic diseases (e.g., asthma, urticaria, eczematous dermatitis); 5.Subjects with positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or Treponema pallidum antibody (TP-Ab); 6. Subjects with a history of drug abuse within 12 months prior to screening or positive urine drug screen during screening; 7. Subjects who regularly consumed alcohol within 6 months prior to screening (averaging >14 units of alcohol per week 1 unit ˜ 285 mL of beer with 3.5% alcohol, 25 mL of spirits with 40% alcohol, or 85 mL of wine with 12% alcohol), or unable to abstain from alcohol from 48 hours prior to dosing until study completion, or with alcohol breath test results >0.0 mg/100 mL during screening; 8. Subjects who smoked an average of >5 cigarettes per day within 3 months prior to screening or unable to abstain from smoking from 48 hours prior to dosing until study completion; 9.Subjects who received blood transfusions or blood products within 3 months prior to screening or experienced blood loss >400 mL for other reasons (excluding physiological blood loss in females); 10. Subjects who participated in other clinical trials within 3 months prior to screening or did not participate in the trial personally; 11.Subjects who used any prescription drugs (including vaccines), over-the-counter drugs, traditional Chinese medicines, or health supplements within 2 weeks prior to screening; 12. Subjects who received vaccinations within 3 months prior to screening or plan to receive vaccinations during the trial; 13. Subjects who consumed xanthine-rich beverages (e.g., coffee, tea) or foods (e.g., animal liver), chocolate, grapefruit, pomelo, mango, or other fruits or juices that may affect metabolism within 48 hours prior to the first dose; 14. Subjects with specific dietary requirements, inability to comply with provided diets and related regulations, or lactose/galactose intolerance; 15. Female subjects who are pregnant or breastfeeding; those who have had unprotected sexual intercourse within 14 days prior to screening; those with a positive blood pregnancy test. 16.16. Subjects who have difficulty swallowing tablets; 16. Subjects who have difficulty swallowing tablets; 17.Subjects who cannot tolerate venipuncture/intravenous cannulation for blood collection or have a history of needle or blood phobia; 18.Other subjects deemed by the investigator as unsuitable for participation in the study; 19.Subjects who voluntarily withdraw.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentration,Cmax;Area under the concentration-time curve of the drug,AUC0-t;Area Under the plasma concentration-time Curve from time zero to infinity,AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak time,Tmax;Adverse event; | — |
Countries
China
Contacts
Public ContactFan Lianlian/Han Yunyun
People's Hospital of Deyang City
Outcome results
None listed