Healthy Subjects
Conditions
Brief summary
The study is being conducted to evaluate the safety, and the relative bioavailability of SHR0302 tablets with three different formulations in healthy subjects.
Interventions
DRUGSHR0302
Group A subjects were given oral F1 、F2 and F3 version SHR0302
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
The relative bioavailability of SHR0302 tablets with three different formulations
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Volunteer to sign an informed consent form before the start of the relevant activities of this trial, understand the procedures and methods of this trial, and be willing to strictly abide by the clinical trial protocol to complete this trial 2. 18\ 45 years old (including both ends, subject to when signing the informed consent form), healthy male 3. Weight ≥ 50 kg, and body mass index (BMI): 19\ 26 kg/m2 (including both ends) 4. Those who have signed the informed consent and have no birth plan within 6 months after the last administration, and agree to take effective contraceptive measures 5. Able to communicate well with the researcher, and understand and comply with the requirements of this research
Exclusion criteria
1. Suspected of being allergic to the study drug or any ingredient in the study drug, or allergic 2. Those who have participated in clinical trials of any drugs and medical devices within six months before screening (subject to the signed informed consent form) 3. Subjects with any systemic inflammatory disease or autoimmune disease 4. Subjects with a history of recurrent herpes zoster, disseminated herpes zoster or disseminated herpes simplex 5. Subjects with a history of malignant tumors 6. Subjects with mental or neurological diseases, unwilling to communicate or have language barriers, unable to fully understand and cooperate 7. Those who have a history of tuberculosis (TB) within six months before screening, or have clinical or imaging evidence of active or occult TB 8. Routine blood examination during the screening period: white blood cell count \<3.0×109/L and/or neutrophil count \<1.5×109/L 9. Subjects Those with serum creatinine\> 1.5 mg/dL (133 μmol/L) at the time of screening 10. At the time of screening, 12-ECG check QTcF\>450 ms or there are other abnormal conditions judged by the investigator to be clinically meaningful 11. Those who are positive for hepatitis B surface antigen, hepatitis C antibodies, syphilis antibodies, and HIV antibodies 12. Those who smoked more than 5 cigarettes daily in the 3 months before screening and cannot stop using any Tobacco products 13. Those who drink regularly in the 6 months before screening, drink more than 14 units of alcohol per week (1 unit = 285 mL of beer, 25 mL of spirits, or 100 mL of wine) and cannot stop using any alcoholic products during the trial; those who have a positive alcohol breath test 14. People who have a history of drug abuse, drug dependence or a positive urine drug abuse screening before administration, including: morphine, methamphetamine (methamphetamine), ketamine, cocaine, ecstasy (dimethylene) Dioxyamphetamine), cannabis (tetrahydrocannabinolic acid) 15. Those who have had any surgery within 6 months before screening 16. Infections that require antimicrobial (virus, bacterial, fungal, and parasitic infections) treatment that occurred within 4 weeks before screening 17. Donated blood (or blood loss) within 3 months before screening and donated blood (or blood loss) ≥400 mL, or received blood transfusion 18. Those who have had any acute disease that has been determined by the investigator to be clinically significant within 1 month before screening 19. Those who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 14 days before taking the study drugs; those who plan to take non-study drugs or health products during the trial period 20. The 48 hours before the first dose until the end of the study, the subject refused to stop any methyl yellow Purine beverages or foods, such as coffee, tea, cola, chocolate, etc.; The 7 days before the first dose until the end of the study, the subject refused to stop using any beverages or foods containing grapefruit; there are special dietary requirements that cannot be consistent Eaters 21. Physical examination, vital signs, laboratory examinations, chest X-ray or chest CT, abdominal ultrasound and other abnormal and clinically meaningful examination results 22. The researcher believes that there are other subjects who are not suitable for participating in the research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The peak plasma concentration (Cmax) of SHR0302. | 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose. | Based on the PK concentration data set, calculate the peak plasma concentration of SHR0302 by non-compartmental analysis. |
| Area Under the Plasma Concentration Versus Time Curve (AUC) of SHR0302. | 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose. | Based on the SHR0302 plasma concentration data set, calculate the Area Under the Plasma Concentration Versus Time Curve of SHR0302 by non-compartmental analysis. |
| The relative bioavailability of SHR0302 tablets with 3 different formulations. | through study completion, an average of 1 month. | The mixed effect model is used to estimate the least square mean difference and 90% confidence interval between different formulations, and then take the antilog to obtain the estimate of the ratio of the least square geometric mean of the corresponding PK parameter and the 90% confidence interval Time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The apparent volume of distribution (Vz/F) of SHR0302. | 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose. | Based on the SHR0302 plasma concentration data set, calculate the apparent volume of distribution of SHR0302 by non-compartmental analysis. |
| The Peak Time (Tmax) of SHR0302. | 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose. | Based on the SHR0302 plasma concentration data set, calculate the time to reach peak plasma concentration of SHR0302 by non-compartmental analysis. |
| Incidence of adverse events. | through study completion, an average of 1 month | laboratory abnormalities (based on hematology, biochemistry, coagulation function, and urinalysis tests), vital sign measurements (include blood pressure, pulse rate, respiratory rate, and body temperature) and 12-Lead electrocardiogram. |
| The Elimination half-life (T1/2) of SHR0302. | 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose. | Based on the SHR0302 plasma concentration data set, calculate the time required for the blood concentration of SHR0302 to drop by half. |
| The Clearance (CL/F) of SHR0302. | 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose. | Based on the SHR0302 plasma concentration data set, calculate the clearance of SHR0302 by non-compartmental analysis. |
Countries
China
Outcome results
None listed