Skip to main content
OpenTrials
Completed

NCT Number: NCT07024888

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Affilated Hospital Of QingDao University

Qingdao, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Special diets (pitaya/grapefruit products) or strenuous exercise within 7 days pre-dosing affecting ADME.
  • Any medication use within 14 days pre-dosing.
  • Regular alcohol >14 units/week within 3 months.
  • Smoking >5 cigarettes/day within 3 months or unwilling to abstain during trial.
  • Caffeine products within 48h pre-dosing.
  • Alcohol consumption within 48h or positive alcohol screen.
  • Positive serology for HBsAg, HCV Ab, HIV Ab, or syphilis.
  • Pregnancy/lactation or unprotected sex
  • Positive drug screen, drug abuse history, or drug use within 3 months.
  • Any condition compromising safety/compliance, or investigator's judgment of unsuitability

Treatment and study plan

SSS17

Drug

Single oral administration of SSS17

Primary outcomes

  1. Cmax

    Time frame: Day1 to Day73

  2. AUC

    Time frame: Day 1 to Day 73

Secondary outcomes

  1. Tmax

    Time frame: Day1 to Day73

  2. t1/2

    Time frame: Day 1 to Day 73

  3. CL/F

    Time frame: Day 1 to Day 73

  4. AEs

    Time frame: up to Day 73

Sponsors and collaborators

Lead sponsor

Shenyang Sunshine Pharmaceutical Co., LTD.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2025
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.