Pain
Conditions
Interventions
Group 1:6 subjects received 50 mg of test drug and 2 subjects received placebo
Group 2:6 subjects received 100 mg of test drug and 2 subjects received placebo
Group 3:6 subjects received 200 mg of test drug and 2 subjects received placebo
Group 4:6 subjects received 400 mg of test drug and 2 subjects received placebo
Group 5:6 subjects received 600 mg of test drug and 2 subjects received placebo
Group 6:6 subjects received 800 mg of test drug and 2 subjects received placebo
300mg dose group:Dosed on an empty stomach in one trial cycle and after consuming a high-fat meal in the other trial cycle
150mg group:8 subjects on 150mg test drug and 2 subjects on placebo (1 male and 1 female) for 10 consecutive days, with dose escalation starting at the lower dose and the next dose only after the prev
300mg group:8 subjects on 300mg test drug and 2 subjects on placebo (1 male and 1 female) for 10 consecutive days, with dose escalation starting at the lower dose and the next dose only after the prev
600mg group:8 subjects on 600mg test drug and 2 subjects on placebo (1 male and 1 female) for 10 consecutive days, with dose escalation starting at the lower dose and the next dose only after the prev
Sponsors
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Subjects must meet all of the following criteria to be enrolled: (1) Informed consent and full understanding of the purpose and significance of this trial prior to the start of any trial-related activities, and and be willing to comply with the trial protocol; 2) Age 18 to 55 years (including borderline values); (3) Male subjects weighing =50.0 kg and female subjects weighing =45.0 kg, body mass index (BMI) = weight (kg)/height 2 (m2), with BMI within the range of 19.0-26.0 kg/m2 (including borderline values); (4) The subject has not had unprotected sex within two weeks prior to screening, and is willing to have no reproductive plans from the start of screening until 3 months after the last dose of the test drug. (4) Subjects who have not had unprotected sex within 2 weeks prior to screening and are willing to take effective contraceptive measures voluntarily from the start of screening to 3 months after the last drug administration.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Subjects meeting one or more of the following criteria will be excluded: (1) Subjects with previous or current circulatory, endocrine, neurological, gastrointestinal, respiratory, genitourinary hematological, immunological, psychiatric, and metabolic abnormalities, or any other disease that could interfere with the test results. disease; 2) A history of allergy to drugs, food or other substances; (3) Those who cannot tolerate venipuncture or have difficulty in collecting blood from a vein, or those who have a history of dizziness from needles or blood; 4) who have undergone surgical procedures within 3 months prior to the trial or who are scheduled to undergo surgical procedures during the study period 5) Those who have taken any medications or supplements (including herbal medicines) within 14 days prior to the trial; (6) Any drug that inhibits or induces hepatic metabolism of the drug (e.g., inducers - barbiturates, carbamazepines, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides) was used within 30 days prior to the trial. (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides (lactones, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 7) Those who participated in any clinical trial and used any clinical trial drug within the 3 months prior to the trial (8) those who donated blood or lost a large amount of blood (=200 mL, excluding female menstrual blood loss), received blood transfusion or used blood products within 3 months prior to enrollment (8) Those who have donated blood or lost a significant amount of blood (=200 mL), received blood transfusion or used blood products within 3 months prior to enrollment (9) pregnant or lactating women, and subjects who are unable to use one or more non-pharmaceutical contraceptive measures during the trial 10) Those with special dietary requirements, those who cannot comply with a uniform diet, or those with swallowing difficulties 11) Those who consume excessive amounts of tea, coffee, and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day 12) Those who tested positive for nicotine prior to the first dose of the study, or those who smoked more than 5 cigarettes per day for 3 months prior to the trial or were unable to stop use of any tobacco product during the trial; (13) Positive alcohol test results prior to the first dose of the study, or regular alcohol users in the 6 months prior to the trial, i.e., drinking more than 14 units of alcohol per week alcohol (1 unit = 360 mL of beer or 45 mL of spirits at 40% alcohol or 150 mL of wine) or cannot stop using any alcoholic product during the trial. those who use any alcohol-containing product; (14) A positive drug test prior to the first study dose or use of soft drugs (e.g., marijuana) in the 3 months prior to the trial or use of hard drugs (e.g., cocaine, cocaine) in the 1 year prior to the trial; (15) abnormal vital signs (systolic blood pressure 100 bpm) or abnormal physical examination, electrocardiogram, chest radiography (orthopantomogram), abdominal B-ultrasound, cardiac ultrasound, laboratory tests Abnormalities in laboratory tests are clinically significant (as judged by the clinical research physician); (16) Posit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration;Pain Threshold;Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dynamic 12-lead electrocardiogram; | — |
Countries
China
Contacts
Public ContactGuoping Yang/Saiying Wang
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed