CompletedPhase 1

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

China36 participantsStarted 2025-03-16

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy adult subjects aged 18 to 45 years
✓. Good health status with no clinically significant medical history.
✓. Agreement to use effective contraception from signing ICF until 6 months after trial completion, with no reproductive plan.
✓. Voluntarily sign informed consent form (ICF), capable of protocol compliance and scheduled follow-up

Exclusion criteria

✕. Hypersensitivity to investigational drug/excipients.
✕. Dysphagia, GI disorders affecting absorption, or relevant surgery history .
✕. Intolerance to venipuncture or needle/blood phobia.
✕. Clinically significant disorders affecting drug ADME.
✕. Clinically significant abnormalities in vital signs/PE/labs/12-lead ECG/chest X-ray at screening.
✕. Family history of malignancy or major surgery within 3 months pre-screening.
✕. Participation in other drug/device trials with investigational product use within 3 months.
✕. Blood donation/loss within 3 months.

What they're measuring

Cmax

Timeframe: Day1 to Day73

AUC

Timeframe: Day 1 to Day 73

Trial details

NCT IDNCT07024888

SponsorShenyang Sunshine Pharmaceutical Co., LTD.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-28

View on ClinicalTrials.gov More Healthy Subjects (HS) trials