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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-16

Study Completion Date

2025-05-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Subjects (HS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Fasting Group

Group Type OTHER

SSS17

Intervention Type DRUG

Single oral administration of SSS17

Low-fat Meal Concomitant Administration Group

Group Type OTHER

SSS17

Intervention Type DRUG

Single oral administration of SSS17

High-fat Meal 2-Hour Post-dose Group

Group Type OTHER

SSS17

Intervention Type DRUG

Single oral administration of SSS17

Interventions

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SSS17

Single oral administration of SSS17

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes