Treatment of osteoarthritis of hip and knee joints
Conditions
Interventions
Sponsors
Huzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Participants must give informed consent to the trial before the trial, and have knowledge of the trial content, process, and potential outcomes Fully understand the current adverse reactions and voluntarily sign a written informed consent form; 2. The subjects are able to communicate well with the researchers and complete the experiment according to the protocol; 3. Gender: Chinese male or female; 4. Age: >= 18 years old; 5. The range of body mass index is 19.0~26.0kg/m^2 [Body mass index=weight/height ^2 (kg/m^2)](including boundary values), male weight >= 50kg, female weight >= 45kg.
Exclusion criteria
Exclusion criteria: 1.Individuals with a history of allergies to diacetylene, anthraquinone derivatives, or any drug components; Individuals who have a history of allergies to two or more drugs, foods, etc; 2.Individuals who have previously experienced intestinal discomfort (especially allergies to the colon), inflammatory bowel disease, intestinal obstruction, pseudo obstruction, unexplained abdominal pain, or a history of liver disease; 3.At present, there are clinically significant diseases related to the respiratory system, circulatory system, digestive system, blood system, endocrine system, immune system, skin system, mental nervous system, and facial features; 4.Currently, there are individuals who have difficulty swallowing or are suspected to have gastrointestinal, liver, or kidney functional status affecting the pharmacokinetics of drugs; 5.Those who have undergone major surgery within 6 months prior to the first administration, or those who plan to undergo surgery during the trial period; 6.Individuals whose vital signs, physical examination, electrocardiogram examination, and laboratory test results show abnormalities with clinical significance; 7.Have one or more cases of hepatitis B, hepatitis C, AIDS, syphilis and/or infectious disease screening Abnormalities with clinical significance; 8.Blood loss within 3 months before the first administration (excluding normal physiological blood loss in females) or blood donation of >= 200mL or blood components (such as plasma, platelets, peripheral blood stem cells, etc.) within 3 months; 9.Within 30 days before the first administration, any changes to the gastrointestinal environment have been used (such as proton pump inhibitors such as metronidazole, omeprazole, lansoprazole, esoprazole, etc.; H2 antagonists such as cimetidine, ranitidine, famotidine, etc.); Sodium bicarbonate, magnesium oxide, aluminum hydroxide, magnesium trisilicate and other antacids; Gastric mucosal protectants such as sucralfate or drugs with liver enzyme activity (such as inducers barbiturates, carbamazepine, phenytoin sodium, dexamethasone, etc.; inhibitors such as SSRI antidepressants, ciprofloxacin, diltiazem, macrolides, metronidazole, ketoconazole, verapamil, fluoroquinolones, etc.); 10.Individuals who have used any medication (including prescription drugs, over-the-counter drugs, Chinese herbal medicines) and health supplements within 14 days prior to the first administration, except for topical medications and eye drops that exert local effects; 11. Those who have stayed up late, consumed spicy and stimulating foods (such as spicy hotpot), or experienced sudden changes in diet and daily life within 7 days before the first administration; Or those who do not agree to stay up late, consume spicy and stimulating foods, or have sudden changes or irregularities in their diet and daily routine before the last dose is taken out of the group; 12.Those who have received the vaccine within one month before the first administration or within one month after the planned trial ends; 13.Individuals who have participated in any clinical trial and taken medication within 3 months prior to the first administration; 14.Individuals with a history of drug abuse within the past 5 years, and/or those who have used drugs within the past 3 months prior to screening, and/or those who have a history of drug abuse Individuals with a history of substance dependence, including those who have tested positive for traditional Chinese medicine or drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;?z;Eliminating terminal half-life;AUC_%Extrap; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Huzhou Central Hospital
Outcome results
None listed