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CompletedNCT06157918Updated Nov 8, 2024

Relative Bioavailability and Food Effect of SYHA1813 Oral Solution in Healthy Participants

A Phase 1 interventional study of SYHA1813 oral solution (2.0g:25mg) and SYHA1813 oral solution (20ml:200mg) in Healthy Participants, sponsored by Shanghai Runshi Pharmaceutical Technology Co., Ltd. Completed at 1 site in China. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-08.

Sponsored by Shanghai Runshi Pharmaceutical Technology Co., Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Male
01

Study summary

This is a three-period crossover phase I study designed to evaluate the relative bioavailability, food effect, safety and tolerability of SYHA1813 oral solution in healthy participants.

Read the detailed description

Avoid duplicating information that will be entered elsewhere, such as Eligibility Criteria or Outcome Measures.

02

Conditions studied

  • Healthy Participants
03

In context

Lead sponsor

Shanghai Runshi Pharmaceutical Technology Co., Ltd is the lead sponsor of 9 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy male aged 18 to 60 years old;
  2. Weight more than 50.0 kg and body mass index between 19 to 26.0 kg/m\^2;
  3. Normal or abnormal results without clinical significance on all tests including medical history, vital signs, physical examination, laboratory evaluation (routine blood, blood biochemistry, urine routine, coagulation function, serum virology, and other related tests), 12-lead electrocardiogram, chest X-ray and other tests;
  4. Male participants and their partners must agree to use effective non-hormonal contraception from the first administration of the test drug to 6 months after the last administration of the test drug, even if permanent contraception has already been used, and the male participant does not plan to donate sperm;
  5. Voluntarily sign the informed consent form, and cooperate in completing the trial according to the protocol.

Exclusion criteria

Exclusion Criteria:

  1. Allergic constitution (allergic to 2 or more kinds of drugs, food, or pollen);
  2. Participants with a clear history of neurological disease or psychiatric disease, a history of severe cardiovascular, hepatic, renal, endocrine, respiratory, hematologic, digestive, immune, and other various systemic diseases, or a history of malignant neoplastic disease;
  3. Participants who are unable to swallow orally administered drugs, or clinically significant abnormalities in gastrointestinal function that could affect drug absorption, distribution, metabolism, and excretion;
  4. Participants who have undergone major surgery within 6 months prior to screening or who are scheduled to undergo surgery during the trial;
  5. Participants with 1 or more abnormal vital signs at screening;
  6. Abnormal and clinically significant electrocardiograms: QTc interval >450ms;
  7. Participants who consumed more than 14 units of alcohol per week in the 4 weeks prior to screening or who had a positive breath test for alcohol at screening;
  8. Smoking ≥ 5 cigarettes per day on average within 6 months prior to screening;
  9. Participants with a history of drug or substance abuse, or a positive urine drug screen;
  10. Participants who have lost blood or donated more than 400 ml of blood within 4 weeks prior to screening or plan to donate blood during the study or within 1 month of the end of the study;
  11. Participants who have participated in other clinical trials within 3 months prior to screening;
  12. Habitual intake of excessive xanthine or caffeine-containing foods, beverages, or other foods that interfere with drug absorption, distribution, metabolism, excretion within 4 weeks prior to screening;
  13. Participants who have taken a special diet (dragon fruit, mango, grapefruit, lime, poppy seed, or food or drink prepared from them) within 7 days prior to screening, or participants who are unable to stop taking the above special diets during the trial;
  14. Participants who have used potent inhibitors or inducers of CYP enzymes (e.g., CYP2C9, 2C19, and 3A4) within 4 weeks prior to screening;
  15. Participants who have used prescription, over-the-counter, herbal, vitamin, or mineral medications within 2 weeks prior to screening, and participants who have taken medications prior to screening that have not completed 5 half-lives, whichever is longer among the various medications;
  16. Participants who cannot tolerate venipuncture or with a history of fainting needle or blood;
  17. Participants who are lactose intolerant;
  18. Any condition that the investigator considers inappropriate for participation in the study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Group 1-sequence ABC

    Participants will sequentially receive SYHA1813 oral solution (2.0g:25mg) fasted (Treatment A), followed by SYHA1813 oral solution (20ml:200mg) fasted (Treatment B), and SYHA1813 oral solution (2.0g:25mg) fed (Treatment C).

    Drug: SYHA1813 oral solution (2.0g:25mg) · Drug: SYHA1813 oral solution (20ml:200mg)

  • Experimental
    Group 2-sequence BCA

    Participants will sequentially receive SYHA1813 oral solution (20ml:200mg) fasted (Treatment B), followed by SYHA1813 oral solution (2.0g:25mg) fed(Treatment C), and SYHA1813 oral solution (2.0g:25mg) fasted (Treatment A).

    Drug: SYHA1813 oral solution (2.0g:25mg) · Drug: SYHA1813 oral solution (20ml:200mg)

  • Experimental
    Group 3-sequence CAB

    Participants will sequentially receive SYHA1813 oral solution (2.0g:25mg) fed (Treatment C), followed by SYHA1813 oral solution (2.0g:25mg) fasted (Treatment A), and SYHA1813 oral solution (20ml:200mg) fasted (Treatment B).

    Drug: SYHA1813 oral solution (2.0g:25mg) · Drug: SYHA1813 oral solution (20ml:200mg)

Interventions

  • DrugSYHA1813 oral solution (2.0g:25mg)

    SYHA1813 oral solution, 25mg, oral

  • DrugSYHA1813 oral solution (20ml:200mg)

    SYHA1813 oral solution, 25mg, oral

06

What researchers measure

Primary outcomes

  1. Cmax

    Maximum observed plasma concentration

    Time frame: Up to 120 hours post-dose for eachperiod

  2. AUC0-∞

    Area under the plasma concentration time curve from time zero extrapolated to infinite time

    Time frame: Up to 120 hours post-dose for eachperiod

  3. AUC0-t

    Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration

    Time frame: Up to 120 hours post-dose for eachperiod

Secondary outcomes

  1. Tmax

    Time of maximum observed plasma concentration

    Time frame: Up to 120 hours post-dose for eachperiod

  2. T1/2

    Terminal elimination half-life

    Time frame: Up to 120 hours post-dose for eachperiod

  3. Title:Cl/F

    Apparent total body clearance

    Time frame: Up to 120 hours post-dose for eachperiod

  4. V/F

    Apparent volume of distribution

    Time frame: Up to 120 hours post-dose for eachperiod

  5. Number of participants with Adverse Events

    Time frame: Up to 34 days

07

Study locations

1 site
  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
    Shanghai, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06157918
Lead sponsor
Shanghai Runshi Pharmaceutical Technology Co., Ltd
Responsible party
Sponsor
First posted
Dec 6, 2023
Start date
Dec 20, 2023
Primary completion
Jan 26, 2024
Completion
Jan 26, 2024
Last update
Nov 8, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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