cough
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 55 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) Male or female aged between 18 and 55 years old (including 18 and 55 years old); 3) Male weight = 50.0kg, female weight = 45.0kg; The body mass index (BMI) is within the range of 18.5-26.0kg/m2 (including the critical value, where BMI=weight (kg)/height (m2)); 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; 5) 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 allergic to dextromethorphan or its excipients (lactose, microcrystalline cellulose, corn starch, talc powder, magnesium stearate), or are known to be allergic to any drug, food, or have a history of specific allergic reactions (such as asthma, rubella, eczema dermatitis), or have a severe allergic constitution, and have been determined by the researcher to have clinical significance; 2) Have a history of dysphagia or any gastrointestinal disease affecting absorption; 3) There is a history of any chronic or serious disease such as blood circulation system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, mental disorder or metabolic abnormality, or any other disease that may interfere with the test results, or a history of surgery within 3 months; 4) Previous history of glaucoma, asthma, or mental illness; 5) Individuals with any disease that increases the risk of bleeding, such as acute gastritis or active ulcer with bleeding, clinically significant thrombocytopenia or anemia, as well as those with active pathological bleeding or a history of intracranial hemorrhage; 6) Poor vascular puncture conditions or inability to tolerate venous puncture; 7) 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 for non medical purposes, or have tested positive for any one or more of the urine addictive drugs such as morphine, methamphetamine (methamphetamine), ketamine, dimethylenedioxymethamphetamine (ecstasy), and tetrahydrocannabinoid acid (marijuana) screening tests; 8) Individuals who have participated or are currently participating in other drug clinical trials within the first 3 months of screening; 9) Blood donation within 3 months prior to screening, including component blood or significant blood loss (= 400mL), receiving blood transfusion or using blood products; Or those who plan to donate blood (including blood components) during or within 3 months after the experiment; 10) Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, and vitamins within the first 14 days of screening; 11) Those who have taken drugs that interact with dextromethorphan hydrobromide within 30 days before screening (including but not limited to NSAID COX 2 inhibitors, antiarrhythmic drugs, monoamine oxidase inhibitor antidepressants, SSRI antidepressants, central nervous system inhibitors, expectorants and mucolytic agents, CYP2D6 inhibitors); 12) Those who have received the vaccine within the first 3 months of screening, or those who plan to receive the vaccine during the trial period; 13) Those who smoke more than 5 cigarettes per day within the first 3 months of screening, or who cannot stop using any tobacco products during the trial period; 14) Individuals with an average daily alcohol intake exceeding 2 units (1 unit=360mL of beer, 150mL of red wine, or 45mL of distilled wine) or positive alcohol breath test results within the first 3 months of screening, or those who do not agree to avoid drinking during the trial period; 15) Drinking excessive amounts of strong tea, coffee, and/or caffeinated beverages (8 or more cups, 1 cup=250mL) every day for the first 3 months prior to screening; 16) Those who have taken strong tea, chocolate, coffe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-8;Tmax;t1/2;?z; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event; | — |
Countries
China
Contacts
Public ContactYang Hui
Guangzhou Panyu District Central Hospital
Outcome results
None listed