A Study Evaluating the Food Effect on the Pharmacokinetics of SSS17 Capsules in Chinese Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Subjects (HS)
• Interventions: Drug: SSS17

• Registration Number: NCT07024888
• Lead Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-16
• Primary Completion: 2025-05-28
• Study Completion: 2025-05-28
• Status Verified: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-09
• Study First Posted: 2025-06-17
• Last Update Submitted: 2025-06-17
• Last Update Posted: 2025-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fasting Group	SSS17	-
Low-fat Meal Concomitant Administration Group	SSS17	-
High-fat Meal 2-Hour Post-dose Group	SSS17	-

Primary Outcome Measures

Name	Time	Method
Cmax	Day1 to Day73
AUC	Day 1 to Day 73

Secondary Outcome Measures

Name	Time	Method
Tmax	Day1 to Day73
t1/2	Day 1 to Day 73
CL/F	Day 1 to Day 73
AEs	up to Day 73

Trial Locations

Locations (1)

The Affilated Hospital Of QingDao University; 🇨🇳 Qingdao, China