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

June 17, 2025 updated by: Shenyang Sunshine Pharmaceutical Co., LTD.

Effect of Food on the Pharmacokinetics of SSS17 Capsules: A Study 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Qingdao, China
        • The Affilated Hospital Of QingDao University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Fasting Group
Drug: SSS17
Single oral administration of SSS17
Other: Low-fat Meal Concomitant Administration Group
Drug: SSS17
Single oral administration of SSS17
Other: High-fat Meal 2-Hour Post-dose Group
Drug: SSS17
Single oral administration of SSS17

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax
Time Frame: Day1 to Day73
Day1 to Day73
AUC
Time Frame: Day 1 to Day 73
Day 1 to Day 73

Secondary Outcome Measures

Outcome Measure
Time Frame
Tmax
Time Frame: Day1 to Day73
Day1 to Day73
t1/2
Time Frame: Day 1 to Day 73
Day 1 to Day 73
CL/F
Time Frame: Day 1 to Day 73
Day 1 to Day 73
AEs
Time Frame: up to Day 73
up to Day 73

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenyang Sunshine Pharmaceutical Co., LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2025

Primary Completion (Actual)

May 28, 2025

Study Completion (Actual)

May 28, 2025

Study Registration Dates

First Submitted

June 5, 2025

First Submitted That Met QC Criteria

June 9, 2025

First Posted (Actual)

June 17, 2025

Study Record Updates

Last Update Posted (Actual)

June 18, 2025

Last Update Submitted That Met QC Criteria

June 17, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • SSS17-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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