postpartum depression
Conditions
Interventions
Single Dose Administration Study - Dose Group 1:Single oral administration of MI078 capsules 50 mg on an empty stomach
Single Dose Administration Study - Dose Group 2:The 2nd to 7th dose groups take MI078 capsules or placebo 100 mg, 200 mg, 400 mg, 600 mg, 800 mg, and 1000mg orally on an empty stomach in the morning o
Food Impact Study - Sequence 1:Seven healthy subjects were selected and administered according to a fasting-postprandial dosing regimen.
Food Impact Study - Sequence 2:Follow a postprandial-fasting dosing regimen.
Multiple Dosing Study - Dose Group 1:A dose of 200 mg was administered and patients were evaluated for tolerability, safety and PK data at 72h (day 10) after 7 days of dosing
Multiple Dosing Study - Dose Group 2:Tolerability, safety, and PK data from the previous dose group at 72h after Day 7 (Day 10) were used to assess whether to proceed with the next dose group. If the
Multiple Dosing Study - Dose Group 3:Tolerability, safety and PK data at 72h after Day 7 administration of the 400mg dose group will be used to assess whether to conduct a study in this dose group. If
Sponsors
Clinical Trial Center of Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Volunteers must meet all of the following criteria to be selected: 1) Age 18~45 years old (including borderline value) :) 2) Male volunteers weighing =50.0kg, female volunteers weighing =45.0kg, with a body mass index (BMI) between 19.0 and 26.0kg/m² (including borderline values). 3) Volunteers scored 0 on the Suicide Risk Assessment Scale (SRAS) at screening; 4) Female volunteers have a regular menstrual cycle of 28±7 days: 5) Volunteers voluntarily signed a written informed consent form.
Exclusion criteria
Exclusion criteria: Volunteers meeting one or more of the following criteria will be excluded: 1) Previous or current serious clinical disease of the circulatory, endocrine, neurological, digestive, respiratory, genitourinary, hematologic, immunologic, psychiatric, or metabolic abnormalities, or any other disease that would interfere with the results of the test; 2) Have other risk factors for torsade de pointes ventricular tachycardia or a family history of first-degree relatives (i.e., biological parents, siblings, or children) with short QT syndrome, long QT syndrome, unexplained sudden death in youth (less than/equal to 40 years of age), drowning, or sudden infant death syndrome; 3) Work with hazardous machinery such as working at heights; 4) a history of allergy to drugs, food or other substances; 5) Vomiting in the volunteer within 24 hours prior to administration of the drug, which has been assessed by the investigator as interfering with the conduct of the trial, or which would compromise the safety of the volunteer if administered; 6) has undergone surgical intervention within 4 weeks prior to the trial or is scheduled to undergo surgical intervention during the study; 7) have taken any medications or supplements (including herbal remedies) within 14 days prior to the trial 8) Use of any drug that inhibits or induces hepatic metabolism of a drug (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, depressants - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, or other drugs that inhibit or induce hepatic metabolism of a drug in the 30 days prior to the study; and Pamil, fluoroquinolones, antihistamines). 9) Participating in any clinical trial and taking any clinical trial medication within 3 months prior to enrollment; 10) Donation of blood or significant blood loss (=200mL, excluding female menstrual blood loss), transfusion or use of blood products within 3 months prior to enrollment: 11) Pregnant or breastfeeding women, and volunteers who are unable to use one or more non-pharmacological contraceptive methods during the trial. 12) Those who have special dietary requirements and are unable to follow a standardized diet; 13) Excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250mL) per day: 14) Excessive intake of citrus-rich beverages or foods (e.g. grapefruit, oranges, etc.) within 48h prior to first admission to the ward; 15) Smokers or those who smoked more than 5 cigarettes per day in the 3 months prior to the trial or those who were unable to stop using any tobacco-based products during the trial; 16) Alcoholics or those who have consumed alcohol on a regular basis during the 6 months prior to the trial, i.e., more than 14 units of alcohol per week (1 unit = 360mL of beer or 45mL of alcohol for the amount of alcohol consumed). (1 unit = 360mL of beer or 45mL of 40% alcohol by volume spirits or 150mL of wine) per week or who are unable to stop using any alcohol-containing product during the trial; 17) Substance abusers or those who have used soft drugs (e.g., marijuana) in the 3 months prior to the trial or hard drugs (e.g., cocaine, phencyclidine, etc.) in the year prior to the trial; 18) Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg. Pulse 100 bpm, respiratory rate 20 breaths) or physical examination,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event;adverse event;physical examination;Twelve-lead electrocardiogram;vital signs;Tmax;Cmax;t1/2;CL/F;AUC0-8;AUC0-t;Vd/F;kel;MRT;Css_av;Css_min;Css_max;Rac;DF; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed