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
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.
Avoid duplicating information that will be entered elsewhere, such as Eligibility Criteria or Outcome Measures.
Shanghai Runshi Pharmaceutical Technology Co., Ltd is the lead sponsor of 9 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
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)
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)
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)
SYHA1813 oral solution, 25mg, oral
SYHA1813 oral solution, 25mg, oral
Cmax
Maximum observed plasma concentration
Time frame: Up to 120 hours post-dose for eachperiod
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
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
Tmax
Time of maximum observed plasma concentration
Time frame: Up to 120 hours post-dose for eachperiod
T1/2
Terminal elimination half-life
Time frame: Up to 120 hours post-dose for eachperiod
Title:Cl/F
Apparent total body clearance
Time frame: Up to 120 hours post-dose for eachperiod
V/F
Apparent volume of distribution
Time frame: Up to 120 hours post-dose for eachperiod
Number of participants with Adverse Events
Time frame: Up to 34 days
Plan to share: No
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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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Shanghai Runshi Pharmaceutical Technology Co., Ltd