A Phase 1 interventional study of SHR6390、Omeprazole in Advanced Solid Tumor, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-08.
Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Basic science
This is a one-arm, fixed-sequence study to compare the pharmacokinetic profiles of SHR6390 in absence and presence of prior administration of proton pump inhibitor Omeprazole. The increased gastric pH achieved by the treatment with multiple doses of Omeprazole might affect the absorption process of SHR6390.
Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: SHR6390、Omeprazole
SHR6390 tablet single dose、Omeprazol single dose.
Cmax
Maximum observed serum concentration (Cmax) for SHR6390 after Single dose.
Time frame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
AUC0-t
Area under the plasma concentration versus time curve (AUC0-t) for SHR6390 after Single dose
Time frame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
AUC0-∞
Area under the plasma concentration versus time curve (AUC0-∞) for SHR6390 after Single dose
Time frame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
Tmax
Time to maximum observed serum concentration (Tmax) for SHR6390 after Single dose
Time frame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
T1/2
Time to elimination half-life (T1/2) for SHR6390 after Single dose.\[Time Frame
Time frame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
CL/F
Apparent oral clearance (CL/F) for SHR6390 after Single dose
Time frame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
Vz/F
Apparent Volume of Distribution (Vz/F) SHR6390 after Single dose
Time frame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
Number of subjects with adverse events and severity of adverse events
Time frame: from Day1 to Day30 after the first dose
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Jiangsu HengRui Medicine Co., Ltd.