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

Shenyang Sunshine Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects (HS)

Treatments: Drug: SSS17

Study type: Interventional

Funder types: Industry

Identifiers

NCT07024888

SSS17-103

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Fasting Group

Other group

Treatment:

Drug: SSS17

Low-fat Meal Concomitant Administration Group

Other group

Treatment:

Drug: SSS17

High-fat Meal 2-Hour Post-dose Group

Other group

Treatment:

Drug: SSS17