None listed
Conditions
Interventions
A:First cycle: Tripterygium glycosides tablet (GTW) 2 tablets
Second cycle: Colquhounia root tablet 5 tablets
Third cycle: Kunxian Capsules 2 capsules
B:First cycle: Colquhounia root tablet 5 tablets
Second cycle: Kunxian Capsules 2 capsules
Third cycle: Tripterygium glycosides tablet (GTW) 2 tablets
C:First cycle: Kunxian Capsules 2 capsules
Second cycle: Tripterygium glycosides tablet (GTW) 2 tablets
Third cycle: Colquhounia root tablet 5 tablets
Sponsors
Tongji Hospital Tongji Medical College of HUST
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Signed informed consent prior to the trial and fully understood the trial content, procedure and possible adverse effects. 2) Male and female subjects = 18 years of age (including 18 years of age). 3) Male subjects weighing not less than 50 kg and female subjects weighing not less than 45 kg. Body mass index (BMI) = weight (kg)/height2 (m2), with BMI in the range of 19.0 to 26.0 (including the critical value). 4) Subjects (including male subjects) who have used effective contraception within 14 days prior to screening and are willing to have no pregnancy plans and voluntarily use effective contraception during the trial and for 6 months after the end of the trial. 5) Able to complete the study in accordance with the requirements of the trial protocol. 6) No history of serious medical conditions such as heart, liver, kidney, nervous system, respiratory system, hematological system, immune system, psychiatric abnormalities and metabolic abnormalities.
Exclusion criteria
Exclusion criteria: 1) Abnormalities judged by the clinician to be clinically significant, including physical examination, vital sign monitoring, electrocardiogram, or clinical laboratory tests; 2) Those with difficult airway, including Modified Marsupial Score Classification III to IV, congenital small mouth and large tongue, mandibular dysplasia, etc.; those with severe snoring or the presence of sleep apnea syndrome; 3) Positive hepatitis B surface antigen, positive hepatitis C antibody, positive HIV antibody or positive syphilis antibody; 4) Those with a history of drug allergy, or allergy (e.g., those who are allergic to two or more drugs, food such as milk and pollen), or those with known allergy to Tripterygium wilfordii genus preparations or other ingredients in the preparations; 5) History of alcohol abuse in the last 6 months (14 units of alcohol per week: 1 unit = 360mL of beer or 45mL of spirits of 40% alcohol or 150mL of wine); or who cannot stop taking any alcohol-containing products during the trial period, or who have a positive alcohol screen; 6) Those with a history of gastrointestinal disorders, particularly any gastrointestinal disorder that interferes with drug absorption (e.g., gastric or small bowel resection, gastric or duodenal ulcers, atrophic gastritis, gastrointestinal bleeding, obstruction, cholecystitis, gallstones, etc.); 7) Female subjects who have used oral contraceptives within the last 30 days or long-acting estrogen or progestin injections or buried tablets within the last 6 months, or who are breastfeeding or have a positive pregnancy test result during the screening period or clinical trial; 8) A positive drug abuse screen (morphine, methamphetamine, ketamine) or a history of drug abuse within the past 5 years or drug use in the 3 months prior to taking the medication being tested; 9) Persons who have smoked more than 5 cigarettes per day on average in the 3 months prior to screening or who are unable to stop using any tobacco-based products during the trial; 10) Blood donation or significant blood loss (>400mL) within 3 months prior to administration of the test drug; 11) History of surgery or participation in other clinical trials of drugs within 3 months prior to administration of the test drug; 12) have taken any prescription medication, any over-the-counter medication, herbal medicine or health supplement within 14 days prior to taking the trial drug; 13) Use of any drug that inhibits or induces hepatic metabolism of a drug (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; depressants - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines) in the 28 days prior to the administration of the experimental drug; 14) Those who have consumed a special diet (e.g., grapefruit and grapefruit-containing products, chocolate-containing, or caffeine-containing, or purine-rich foods, fruits such as kiwifruit, oranges, mandarin oranges, dragon fruits, guava, etc.), or any other factors that affect the absorption, distribution, metabolism, or excretion of the drug, within 48 hours prior to administration of the experimental drug; 15) Those who have received vaccination within 1 month prior to taking the experimental drug; 16) those who have special dietary requirements during the study period and cannot be on a uniform diet; 17) Those who cannot tolerate venipuncture or have a history of blood or needle sicknes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters; | — |
Countries
China
Contacts
Public ContactZheng Heng
Tongji Hospital Tongji Medical College of HUST
Outcome results
None listed