Chronic pain
Conditions
Interventions
Group A:Twenty-four volunteers, both male and female, were planned to be enrolled and randomized into groups A and B, with 12 cases in each group. Two dosing cycles with two dosing regimens (T1 and T2
Group B:Twenty-four volunteers, both male and female, were planned to be enrolled and randomized into groups A and B, with 12 cases in each group. Two dosing cycles with two dosing regimens (T1 and T2
Sponsors
Clinical Trial Center of Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be enrolled, volunteers must meet all of the following criteria: 1) The volunteer fully understands the purpose, nature, methods, and possible adverse effects of the trial, volunteers voluntarily as a volunteer, and signs an informed consent form prior to the start of any study procedures; 2) The volunteer is able to communicate well with the investigator and understands and complies with the requirements of the study; 3) Volunteers (including male volunteers) are using effective contraception within 14 days prior to the trial and are willing to have no pregnancy plans and voluntarily use effective contraception during the trial and for 6 months after the last dose; 4) Male and female volunteers aged 18 to 65 years (including the threshold); 5) Male volunteers weighing no less than 50 kg. Female volunteers weighing no less than 45 kg. Body mass index (BMI) = weight (kg)/height2 (m2), with BMI in the range of 19.0 to 26.0 (including critical values);
Exclusion criteria
Exclusion criteria: Volunteers who meet one or more of the following criteria will be excluded: 1) Persons with any previous or current clinically serious disease of the circulatory, endocrine, neurological, digestive, respiratory, genitourinary, hematological, immunological, psychiatric and metabolic abnormalities or any other disease that can interfere with the results of the test; 2) A personal history or family history of a psychiatric disorder (e.g., major depressive disorder) 3) A history of allergy to drugs, food or other substances 4) have undergone surgical procedures within 4 weeks prior to the trial or are scheduled to have surgical procedures during the study 5) those who have taken any medication or supplements (including herbal remedies) within 14 days prior to the trial 6) Any drug that inhibits or induces hepatic metabolism of drugs within 30 days prior to the trial (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil (Pami, fluoroquinolones, antihistamines); 7) Those who participated in any clinical trial and took any clinical trial drug within the 3 months prior to the trial 8) those who have donated blood or lost a significant amount of blood (>=200 mL, excluding blood loss during menstruation in women), received a blood transfusion or used blood products within 3 months prior to enrollment 9) Pregnant or lactating women, and those who cannot use one or more non-pharmaceutical contraceptive measures during the volunteer trial 10) Those who have special dietary requirements and cannot comply with a uniform diet 11) Those who consume excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day 12) smokers or those who smoked more than 5 cigarettes per day in the 3 months prior to the trial or those who could not stop using any tobacco-based products during the trial 13) alcoholics (including alcohol abuse or addiction) or regular drinkers in the 6 months prior to the trial, i.e., those who consume 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 those who are unable to stop using any alcohol-containing products during the trial 14) Substance abusers (including drug abuse or addiction) 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 1 year prior to the trial 15) Those with abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm) or abnormal physical examination, electrocardiogram, or laboratory tests of clinical significance (as judged by the clinical study physician); 16) Those with a history of postural hypotension, needle or blood sickness or intolerance to venipuncture blood collection; 17) Those who have received vaccines within 1 month prior to the trial or who plan to receive vaccines during the trial 18) Volunteers who may not be able to complete the study for other reasons or who, in the opinion of the investigator, should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK Indicators;adverse events;laboratory test;Physical examination; vital signs;Twelve-lead electrocardiogram; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed