hypercholesterolemia
Conditions
Interventions
Group A:In the first cycle, the drug was administered on an empty stomach, and in the second cycle, the drug was administered after a high-fat meal
Group B:In the first cycle, the drug was administered after a high-fat meal, and in the second cycle, the drug was administered on an empty stomach
Sponsors
Shanghai Xuhui Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old50 kg, female>45 kg; 19 kg/m2<Body Mass Index (BMI)<28 kg/m2; 3. No history of diseases such as heart, lung, liver, kidney, digestive tract, nervous system, mental disorders, and metabolic abnormalities; 4. Physical examination, vital signs examination, electrocardiogram examination, laboratory examination indicators, abdominal ultrasound, etc. are all normal or within the acceptable range considered by the applicant/researcher; 5. During the trial period and within 6 months after the last medication administration, there is no parenting plan and reliable contraceptive measures can be taken; 6. Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, able to complete the entire trial process according to the trial requirements.
Exclusion criteria
Exclusion criteria: 1. Those who have a known history of allergies, allergic diseases, or allergic constitution to the experimental preparation, any of its components, or related preparations; 2. Have a clear medical history of central nervous system, cardiovascular system, digestive system, respiratory system, Urinary system, blood system, metabolic disorders, etc. or other diseases (such as psychiatric history, etc.) that are not suitable for clinical trials; 3. Those who have donated blood or lost more than 400mL of blood within the first three months of selection; 4. Those who have taken any medication within the first 2 weeks of screening; 5. Those who have participated in clinical trials of other drugs within the first three months of selection; 6. Those who are currently or have been drug users, or those who have tested positive for drug abuse; 7. Current or past alcoholics (drinking more than 14 standard units per week. 1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine), or those who have tested positive for alcohol breath test; 8. Those who smoke more than 10 cigarettes per day; 9. Persons with positive HBsAg (HBsAg), HCV antibody, Treponema pallidum antibody and HIV antibody; 10. Those with abnormal chest X-ray (posterior anterior position) results and clinical significance; 11. Pregnancy test positive (applicable to women); 12. Researchers believe that there are other factors that are not suitable for participating in the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) characteristics of single oral administration of BGT-002 tablets; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital sign examination;physical examination;ECG;laboratory examination; | — |
Countries
China
Contacts
Public ContactChen Yu
Shanghai Xuhui Central Hospital
Outcome results
None listed