rheumatoid arthritis
Conditions
Interventions
TR: Group TR was administered the text drug in the first phase
after 7 d of washout, cross-administration (the second phase) was performed. The reference drug was administered in the second phase.
RT: Group RT was administered the reference drug in the first phase
after 7 d of washout, cross-administration (the second phase) was performed. The text drug was administered in the second phase.
Sponsors
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Volunteers met all of the following inclusion criteria to be enrolled in this study: 1) Fully understand the purpose, identification, method, and possible adverse reactions of the study; voluntarily serve as subjects; sign an informed consent personally before the start of any research procedure; and guarantee to participate in the study personally throughout the research; 2) Male and female aged 18–45 years (including 18 and 45 years), with an appropriate sex ratio; 3) Male weight >= 50.0 kg, female weight >= 45.0 kg; body mass index (BMI) in the range of 18.5 to 26.0 kg/m^2 (including the critical value); 4) Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry, blood transfusion four items, coagulation function, blood pregnancy test (female), alcohol breath test, drug abuse screening, 12-lead electrocardiogram, chest X-ray examination results show no abnormalities or abnormalities are not clinically significant; 5) No plan to become pregnant during the screening period and the next 3 months and voluntarily take effective contraceptive arrangements and have no sperm or egg donation plan; 6) Be able to communicate well with researchers and understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: Any of the following conditions lead to exclusion: 1) a known allergy to any drug or food, a history of specific allergic reactions (such as asthma, rubella, and eczematous dermatitis), or a severe allergic system judged by the investigator to have clinical significance; 2) a history of chronic disease of the circulatory, digestive, urinary, respiratory, nervous, immune, secretory, mental, or metabolic systems, or any other disease that may interfere with the results of the study or that may pose a safety risk due to the use of the investigational drug, or a history of surgery within the past three months; 3) poor vascular puncture conditions, inability to tolerate venipuncture, and a history of fainting from needles or blood; 4) a history of drug use or abuse in the six months prior to screening, including repeated, heavy use of narcotic drugs and psychotropic substances, or urine addictive drugs morphine, methamphetamine (methamphetamine), ketamine, dimethylene dioxyamphetamine (ecstasy), tetrahydrocannabinol (cannabis) screening study any one or more results are positive; 5) participated in or are participating in other drug clinical researches within three months prior to screening; 6) donated blood, including component blood or large blood loss (>= 400 mL) (excluding blood loss during female menstrual period) within three months of screening, received a blood transfusion or used blood products, or intend to donate blood (including blood components) during or within 3 months after the end of the study; 7) pregnant, breastfeeding, or the woman had unprotected sex or a positive blood pregnancy test within 14 days before the planned drug administration; 8) use of prescription drugs, over-the-counter drugs, or Chinese herbs and vitamins within 14 days before screening; 9) use of inhibitors and inducers of the liver metabolic enzyme CYP3A4, or drugs that have drug interactions with dexamethasone (e.g., Barbiturate derivatives, salicylic acid derivatives, anticoagulants, oral hypoglycemic agents, insulin preparations, diuretics (except potassium-conserving diuretics), cyclosporine, HIV protease inhibitors, macrolide antibiotics, and non-depolarizing muscle relaxants) within 28 days before screening; 10) received inactivated vaccine within one month before screening or planned to receive inactivated vaccine within one month after the end of the study or received vaccines other than inactivated vaccines, including but not limited to live attenuated vaccines, adenovirus vector vaccines, subunit recombinant vaccines, and genetic vaccines, within three months before screening, or plan to receive vaccines other than inactivated vaccines within three months after study completion; 11) smokers who smoke more than five cigarettes per day within three months prior to screening, or those who could not stop using tobacco products during the study period; 12) alcohol intake averaged more than two units per day (1 unit =360 ml beer, 150 ml red wine, or 45 mL distilled spirits) in the three months prior to screening, or tested positive for alcohol, or did not agree to avoid alcohol consumption during the study period; 13) excessive consumption of strong tea, coffee, and other caffeinated beverages (more than eight cups, 1 cup =250 mL, daily) within 3 months prior to screening; 14) ingested strong tea, chocolate, coffee, or food or drink containing caffeine, alcohol, xanthine (such as anchovy, sardines, ox liver, ox kidney, etc.), or grapefruit (juice) w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax ;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;T1/2;?z;AUC_%Extrap ; | — |
Countries
Chinese
Contacts
Public ContactYang Hui
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Outcome results
None listed