Metal Disease
Conditions
Interventions
Fasting Group T-R:T-R
Fasting Group R-T:R-T
Fed Group T-R:T-R
Fed Group R-T:R-T
Sponsors
Beijing Shijitan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Be a healthy man or woman between 18 and 55 years of age, inclusive. It is suggested to enroll female subjects not less than a quarter of the total subjects; 2. Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study and adhere to the prohibitions and restrictions specified in this protocol; 3. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for subject participating in clinical studies. Before randomization, a woman must be either: (1) Not of childbearing potential defined as: postmenopausal A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level (>40 IU/L or mIU/mL in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy, however in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient; permanently sterile Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy. (2) Of childbearing potential and practicing a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly); Examples of highly effective contraceptives include user-independent methods: implantable progestogen-only hormone contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); vasectomized partner; sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the subject.) user-dependent methods: combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, and transdermal; progestogen-only hormone contraception associated with inhibition of ovulation: oral and injectable. Typical use failure rates may differ from those when used consistently and correctly. Use should be consistent with local regulations regarding the use of contraceptive methods for subjects participating in clinical studies. Hormonal contraception may be susceptible to interaction with the study drug, which may reduce the efficacy of the contraceptive; agrees to remain on a highly effective method throughout the study and for at least 30 days after the last dose of study drug. Note: If the childbearing potential changes after start of the study (eg, a woman who is not heterosexually active becomes active,) a woman must begin a highly effective method of contraception, as described throughout the inclusion criteria; 4. If a woman, must have a negative serum pregnancy test at screening and on Day -1 of each treatment period; 5. If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 2 months after receiving the last dose of study drug; 6. If a man who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use an adequate contraceptio
Exclusion criteria
Exclusion criteria: 1. History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), gastrointestinal disease, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results; 2. Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or on Day -1 of each treatment period as deemed appropriate by the investigator; 3. Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram (ECG) at screening or on Day -1 of each treatment period as deemed appropriate by the investigator; 4. Presence of orthostatic hypertension at screening, defined as a fall in systolic blood pressure of at least 20 mm Hg or diastolic blood pressure of at least 10 mm Hg compared to supine position when the subject assumes a standing position. See Section 6.3 for measurement procedure; 5. Use of any drug that may inhibit or induce liver metabolism within 30 days prior to the study (eg, inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolide, nitroimidazole, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, etc.) 6. Use of any prescription or nonprescription medication within 14 days prior to scheduled administration of the first dose of study drug, including vitamins and herbal supplements such as hypericum perforatum (St. John's wort), except for oral contraceptives, paracetamol (acetaminophen), and persistent use of hormones IUD); 7. Frequent consumption of alcohol within 6 months prior to the study, i.e. consumption of more than 14 units of alcohol each week (1 unit = 17.7 mL of ethanol, i.e. 1 unit = 357 mL of bear containing 5% alcohol or 44 mL of liquor containing 40% alcohol or 147 mL of wine containing 12% alcohol); or positive test for alcohol breath test on Day -1 of each treatment period; 8. Positive test for drug screening, such as cannabinoids, opiates, cocaine, amphetamines, benzodiazepines, or ketamine on Day -1 of each treatment period; 9. Drug abusers or use of soft drugs (eg, cannabis) within 3 months prior to the study or hard drugs (eg cocaine, benzene cyclohexylidene, etc.) within 1 year prior to the study; 10. History of clinically significant allergies and known allergy to the study drug or any of the excipients of the formulation (eg, lactose, refer to the Investigator Brochure or local package insert for details); 11. Donated blood or blood products or had substantial loss of blood (more than 400 mL) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study; 12. Received an experimental drug or used an experimental medical device within 3 month or within a period less than 10 times the drugs half-life, whichever is longer, before the first dose of the study drug is scheduled. 13. Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug); 14. If a woman,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Pressure;Pulse;Respiration;Temperature;ECG;Blood Routine Examination;Routine Urine Examination;Blood Biochemical; | — |
Countries
China
Contacts
Public ContactXinghe Wang
Beijing Shijitan Hospital Capital Medical University
Outcome results
None listed