Moderate to severe pain
Conditions
Interventions
Fasting Group A:Take the test formulation in the first cycle and the reference formulation in the second cycle.
Fasting Group B:Take the reference formulation in the first cycle and the test formulation in the second cycle.
Postprandial Group A:Take the test formulation in the first cycle and the reference formulation in the second cycle.
Postprandial Group B:Take the reference formulation in the first cycle and the test formulation in the second cycle.
Sponsors
Guangzhou Panyu District Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Fully understand the purpose, nature, methods, and potential adverse reactions of the experiment, voluntarily act as a subject, and sign an informed consent form by myself before any research procedure begins, and ensure that I participate in the experiment throughout the entire process; 2) For men and women aged 18 to 65 (including 18 and 65), the sex ratio is appropriate; 3) Male weight = 50.0kg, female weight = 45.0kg; Body mass index (BMI) within the range of 18.5-26.0kg/m2 (including critical values); 4) During the screening period and within the next 3 months, there is no pregnancy plan and effective contraceptive measures are voluntarily taken (Appendix 2), and there is no plan to donate sperm or eggs; Those who are able to communicate well with researchers and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1) Individuals who are known to be allergic to any medication, food, or have a history of specific allergic reactions (such as asthma, rubella, eczematous dermatitis) or have a severe allergic constitution, and have been determined by researchers to have clinical significance; 2) Have a history of dysphagia or any gastrointestinal disease affecting absorption; 3) The patient has a history of any chronic or serious disease such as blood circulation system, digestive system, urinary system, respiratory system (especially bronchial asthma), nervous system (especially epilepsy), immune system, endocrine system, mental disorder (especially suicidal thoughts) or metabolic abnormality, or any other disease that may interfere with the test results, or a history of surgery within 3 months; 4) Individuals with previous or current orthostatic hypotension; 5) Those with poor vascular puncture conditions, or those who cannot tolerate venous puncture, or those with a history of needle and blood fainting; 6) Individuals with a history of drug abuse within the first 6 months of screening, or those who have used drugs within the first 3 months of screening, including those who repeatedly and extensively use various types of narcotic drugs and psychotropic substances, or have tested positive for any one or more of the urine addiction drugs such as morphine, methamphetamine (methamphetamine), ketamine, dimethylenedioxyphetamine (ecstasy), and tetrahydrocannabinoid acid (cannabis) screening tests; 7) Individuals who have participated or are currently participating in other drug clinical trials within the first 3 months of screening; 8) Those who donate blood within the first 3 months of screening, including component blood or a large amount of blood loss (= 400mL) (excluding blood loss during female menstruation), and those who receive blood transfusions or use blood products; Or those who plan to donate blood (including blood components) during or within 3 months after the experiment; 9) Women who are in pregnancy, lactation, or have unprotected sexual activity or positive blood pregnancy test results within 14 days before the planned medication administration; 10) Female subjects who have used oral contraceptives within 30 days prior to screening or long-term estrogen or progesterone injections or implants within 6 months prior to the trial; 11) Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, and vitamins within the first 14 days of screening; 12) Those who have used any drugs to inhibit or induce liver drug enzymes within 30 days before screening (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, etc.; inhibitors - ketoconazole, omeprazole, itraconazole, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotic, verapamil, fluoroquinolones, antihistamines, etc.), see Appendix 5 for details; 13) Those who have received vaccines within 4 weeks before screening or those who plan to receive vaccines during the trial period; 14) Those who smoke more than 5 cigarettes per day within the first 3 months of screening, or those who cannot stop using any tobacco products during the trial period; 15) Individuals with an average daily alcohol intake exceeding 2 units (1 unit=360mL of beer, 150mL of red wine, or 45mL of distilled wine) within the first 3 months of screening, or those who have tested positive for alcohol breath, or those who do not agree to avoid drinking during the tr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-8;AUC0-t; | — |
Countries
China
Contacts
Public ContactYang Hui
Guangzhou Panyu District Central Hospital
Outcome results
None listed