Primary hypercholesterolemia and Mixed dyslipidemia
Conditions
Interventions
Fasting T-R-T-R:Take 1 tablet of rosuvastatin ezetimibe once per cycle (I), on an empty stomach in the order of T-R-T-R, with a washout period of 10 days, and about 240 mL of water when administering.
Fasting R-T-R-T:Take 1 tablet of rosuvastatin ezetimibe once per cycle (I), on an empty stomach in the order of R-T-R-T, with a washout period of 10 days, and about 240 mL of water when administering.
Fed T-R-T-R:Take one tablet of rosuvastatin ezetimibe once per cycle (I), following the T-R-T-R sequence after meals, with a 10-day washout period. Take with approximately 240 mL of water.
Fed R-T-R-T:Take one tablet of rosuvastatin ezetimibe once per cycle (I), following the R-T-R-T sequence after meals, with a 10-day washout period. Take with approximately 240 mL of water.
Sponsors
Shanxi Provincial People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Chinese adults aged >=18 years, both male and female. 2. Weight requirements: males >=50.0 kg, females >=45.0 kg, and Body Mass Index (BMI) between 19.0 and 26.0 kg/m^2 (inclusive, BMI = weight [kg] / height [m]^2). 3. At screening, participants must have normal results or abnormalities of no clinical significance (as judged by a clinician) in comprehensive physical examination, vital signs, 12-lead ECG, and specified laboratory tests, and researchers must consider the participant healthy with good mental status. 4. From the time of signing the informed consent until 3 months after the last dose, participants must be willing to use effective contraception to avoid pregnancy or fathering a child, and must have no plans to donate sperm or eggs. 5. Participants must be able to communicate smoothly with the researchers, fully understand and strictly follow the study procedures, voluntarily participate, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of drug allergy (especially known or suspected allergy to ezetimibe, rosuvastatin, or any excipients in this product) or history of atopic or hypersensitivity diseases (asthma, urticaria, eczematous dermatitis, etc.) or severe allergic constitution (known allergy to three or more drugs or foods). 2. History or current presence of severe systemic diseases (such as musculoskeletal, nervous, endocrine, cardiovascular, respiratory, digestive, urinary, reproductive system diseases, etc.) or psychiatric disorders. 3. History of syncope related to blood or needles, or inability to tolerate venous blood collection with an indwelling needle. 4. Presence of diseases that may affect drug absorption, distribution, metabolism, excretion, or interpretation of safety data, or diseases that may reduce adherence, including but not limited to: - Inflammatory bowel disease, gastric ulcer, duodenal ulcer, gastrointestinal/rectal bleeding, persistent nausea, or other clinically significant gastrointestinal abnormalities; - History of major gastrointestinal surgery (e.g., gastrectomy, gastrointestinal anastomosis, intestinal resection, gastric bypass, gastric partition surgery, gastric banding, cholecystectomy, excluding appendectomy and rectal prolapse surgery); 5. History or current hypothyroidism, rhabdomyolysis, hereditary muscle diseases, obstructive gallbladder or biliary diseases, chronic renal failure, pancreatitis, etc. 6. History of active liver disease or persistently unexplained elevated serum transaminases. 7. History of myopathy, muscle pain, or hereditary muscle diseases. 8. Undergoing surgery within 3 months prior to the trial or planning surgery during the trial. 9. Smoking an average of more than 5 cigarettes per day within 3 months before the trial or inability to abstain from smoking throughout the trial. 10. Regular alcohol consumption within 3 months prior to the trial (i.e., an average of more than 2 units of alcohol per day; 1 unit = 17.7 mL ethanol, equivalent to 357 mL of 5% beer, 43 mL of 40% liquor, or 147 mL of 12% wine) or inability to abstain from alcohol during the trial. 11. Blood donation or blood loss >=400 mL within 3 months prior to the trial (excluding menstruation) or planning to donate blood during the trial or within 3 months after the trial. 12. Participation in other clinical trials with investigational drugs or medical devices within 3 months prior to this trial. 13. Use of illicit drugs within 3 months prior to the trial or history of drug abuse within 12 months. 14. Use of any drugs inhibiting or inducing hepatic drug-metabolizing enzymes within 4 weeks prior to the trial (e.g., inducers: rifampicin, carbamazepine, phenytoin; inhibitors: cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines) or any drugs interacting with ezetimibe, rosuvastatin, or their excipients. 15. Use of prescription drugs, over-the-counter drugs, vitamins, health supplements, Chinese herbal medicines, proprietary Chinese medicines, or products containing Chinese medicine ingredients within 2 weeks prior to the trial. 16. Female participants who are pregnant or breastfeeding prior to the trial. 17. Vaccination within 2 weeks prior to the trial or planning vaccination during the trial. 18. Unwillingness to avoid specific foods for 48 hours before each dosing cycle until the end of the trial (including dragon fruit, mango, grapefrui
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of unbound ezetimibe;AUC0–t of unbound ezetimibe;AUC0–8 of unbound ezetimibe;Cmax of total ezetimibe;AUC0–t of total ezetimibe;AUC0–8 of total ezetimibe;Cmax of rosuvastatin;AUC0–t of rosuvastatin;AUC0–8 of rosuvastatin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Other PK parameters (Tmax, t1/2, ?z, CL/F, Vd/F, AUC%Extrap); | — |
Countries
China
Contacts
Public ContactHui Liao
The Fifth Clinical Medical College of Shanxi Medical University; Shanxi Provincial People’s Hospital
Outcome results
None listed