Primary hypercholesterolemia, homozygous familial hypercholesterolemia and homozygous sitosteremia
Conditions
Interventions
Fasting:phase I: T/R
phase II: R/T
High-fat meal:phase I: T/R
Sponsors
The Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Chinese healthy volunteers between the ages of 18 and 60 (including boundary values) men and women; 2) The weight of male volunteers is >= 50.0 kg, the weight of female volunteers is >= 45.0 kg, and the body mass index (BMI) is 19 to 26 kg / m2 (including the boundary value). Body mass index (BMI) = body weight (kg) / height 2 (m2); 3) Sign the informed consent before the test, and fully understand the test content, process, and possible adverse reactions; 4) Volunteers can communicate well with researchers and understand and abide by the requirements of this research.
Exclusion criteria
Exclusion criteria: 1) Those who has or is currently suffering from circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric and metabolic abnormalities, or any other serious clinical disease that can interfere with the test results; 2) A history of allergy to drugs, food or other substances; 3) Those who have received surgery within 4 weeks prior to the study, or plan to perform surgery during the study period; 4) Those who have taken any medicine or health care product (including Chinese herbal medicine) within 14 days before the test; 5) Any drug that inhibits or induces liver drug metabolism (e.g., inducers -- barbiturates, carbazepine, phenytoin, glucocorticoids, omeprazole) was administered within 30 days prior to the test;SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines); 6) Those who took any drug in the clinical trial or participated in any drug clinical trial within 3 months before the trial; 7) Blood donors within 3 months before the test; 8) Pregnant and lactating women, or those who are unable to use one or more non-drug contraceptives during the trial period; 9) Those who have special requirements on diet and cannot follow a unified diet; 10) Excessive daily consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 mL); 11) Smokers or those who smoked more than 5 cigarettes per day in the 3 months before the study, and those who could not be smoke-free during the study hospitalization; 12) Alcoholics or frequent drinkers in the 6 months prior to the trial, i.e., drinking more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL spirits of 40% alcohol or 150 mL wine); 13) Drug abusers or users of soft drugs (e.g., marijuana) in the 3 months prior to the trial or hard drugs (e.g., cocaine, phenylhexidine, etc.) in the 1 year prior to the trial; 14) patients with abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg;Heart rate 100 BPM) or abnormalities in physical examination, electrocardiogram or laboratory examination are clinically significant (subject to the judgment of the clinician); Subjects who may not be able to complete the study for other reasons or who the investigator considers should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital, Central South University
Outcome results
None listed