None listed
Conditions
Interventions
AB group:High ester meal
BA group:High ester meal
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy adult male and female subjects; 2) Age: 18-45 years old; 3) Body weight: Body mass index should be between 19.0 and 26.0 kg/m2 (including the boundary value), the body weight of male subjects should not be less than 50 kg, and the body weight of female subjects should not be less than 45 kg; 4) Voluntarily sign the informed consent; 5) The subject can communicate well with the investigator and complete the experiment according to the protocol.
Exclusion criteria
Exclusion criteria: 1) Abnormal physical examination, vital signs, 12-lead electrocardiogram, laboratory tests and other examinations with clinical significance; 2) Hepatitis B surface antigen or E antigen or hepatitis B E antibody or hepatitis B core antibody, hepatitis C antibody, HIV antibody or syphilis antibody positive; 3) Use of any drug that inhibits or induces liver drug-metabolizing enzymes within 30 days prior to the screening period; 4) Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines or food supplements, such as vitamins and calcium supplements, within 14 days prior to the screening period; 5) Any history of clinically serious illness or disease or condition that the investigator believes may affect the results of the trial, including but not limited to a history of circulatory, respiratory, endocrine, nervous, digestive, urinary, or hematological, immune, psychiatric, and metabolic disorders; 6) A history of any conditions that may affect drug absorption, such as gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy, inflammatory bowel; 7) history of patients with organic heart disease, heart failure, history of myocardial infarction, angina pectoris history, can not explain the history of history of cardiac arrhythmias, ventricular tachycardia, atrioventricular block and lengthened QT syndrome history or have QT syndrome symptoms and family history; 8) Patients who have undergone any surgery within 6 months before the screening period; 9) Allergic constitution, such as a known history of allergy to two or more substances; Or may be allergic to the trial drug or its excipients as judged by the investigator; 10) Heavy drinking or regular drinking in the 6 months prior to the screening period, i.e. drinking more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine); Or a positive alcohol breath test result during the screening period; 11) Users who used nicotine-containing products 3 months before screening and during the study period; 12) Those with a history of drug abuse or drug use within 3 months before the screening period; Or positive urine drug test during the screening period; 13) Those who habitually consume grapefruit juice or excessive tea, coffee and/or caffeinated beverages and are unable to abstain during the trial period; 14) Patients with a history of needle sickness and blood sickness, difficulty in blood collection or intolerance to venipuncture blood collection; 15) Participated in any other clinical trials (including drug and device trials) within 3 months prior to the screening period; 16) Those who had been vaccinated within 1 month before screening or planned to be vaccinated during the trial period; 17) Pregnant or lactating women; 18) Those who planned to have children or donate sperm during the trial and within 6 months after the completion of the trial, or those who did not agree that the subject and his/her spouse should take strict contraceptive measures during the trial and within 6 months after the completion of the trial (see Appendix 4 for details); 19) Blood loss or blood donation of 400 mL within 3 months before the screening period, or receiving blood transfusion within 1 month; 20) Subjects with any factors deemed inappropriate by the investigator for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The area under the plasma concentration-time curve from zero time to the last measured concentration;Area under the plasma concentration-time curve from zero time to inferred infinite time;Maximum plasma concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events;Vital signs;Laboratory examination;Routine 12-leads electrocardiogram;physical examination; | — |
Countries
China
Contacts
Public ContactLiu Dongyang
Outcome results
None listed