Healthy Subjects (HS)
Conditions
Brief summary
This study mainly compared the blood drug concentration and main pharmacokinetic parameters of SSS17 capsules taken orally once by healthy Chinese subjects under fasting conditions, 2 hours after administration, and when consuming a high-fat meal or a low-fat meal simultaneously. The study evaluated the impact of food on SSS17 capsules.
Interventions
DRUGSSS17
Single oral administration of SSS17
Sponsors
Shenyang Sunshine Pharmaceutical Co., LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult subjects aged 18 to 45 years 2. Good health status with no clinically significant medical history. 3. Agreement to use effective contraception from signing ICF until 6 months after trial completion, with no reproductive plan. 4. Voluntarily sign informed consent form (ICF), capable of protocol compliance and scheduled follow-up
Exclusion criteria
1. Hypersensitivity to investigational drug/excipients. 2. Dysphagia, GI disorders affecting absorption, or relevant surgery history . 3. Intolerance to venipuncture or needle/blood phobia. 4. Clinically significant disorders affecting drug ADME. 5. Clinically significant abnormalities in vital signs/PE/labs/12-lead ECG/chest X-ray at screening. 6. Family history of malignancy or major surgery within 3 months pre-screening. 7. Participation in other drug/device trials with investigational product use within 3 months. 8. Blood donation/loss within 3 months. 9. Special diets (pitaya/grapefruit products) or strenuous exercise within 7 days pre-dosing affecting ADME. 10. Any medication use within 14 days pre-dosing. 11. Regular alcohol \>14 units/week within 3 months. 12. Smoking \>5 cigarettes/day within 3 months or unwilling to abstain during trial. 13. Caffeine products within 48h pre-dosing. 14. Alcohol consumption within 48h or positive alcohol screen. 15. Positive serology for HBsAg, HCV Ab, HIV Ab, or syphilis. 16. Pregnancy/lactation or unprotected sex 17. Positive drug screen, drug abuse history, or drug use within 3 months. 18. Any condition compromising safety/compliance, or investigator's judgment of unsuitability
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax | Day1 to Day73 |
| AUC | Day 1 to Day 73 |
Secondary
| Measure | Time frame |
|---|---|
| Tmax | Day1 to Day73 |
| t1/2 | Day 1 to Day 73 |
| CL/F | Day 1 to Day 73 |
| AEs | up to Day 73 |
Countries
China
Outcome results
None listed