A Phase 1 interventional study of Hetrombopag Olamine Tablet;Ciclosporin Soft Capsule in Sever Aplastic Anaemia, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-10-21.
Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment
This is a single-center, single-arm, open-label, self-controlled, phase I clinical study. A total of 26 male or female healthy subjects are intended to be enrolled to evaluate the PK drug-drug interaction between ciclosporin and hetrombopag.
343 studies on the registry are indexed under Anemia, Aplastic; 99 are open to participants now.
This study's enrollment of 26 is below the median of 39 across 268 interventional studies indexed under Anemia, Aplastic.
Browse Anemia, Aplastic studies →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: Hetrombopag Olamine Tablet;Ciclosporin Soft Capsule
Drug: Hetrombopag Olamine Tablet Ciclosporin Soft Capsule
Peak hetrombopag plasma concentration (Cmax)
Time frame: 0-120 hours post dose
Area Under the plasma hetrombopag concentration vs time curve (AUC0-120)
Time frame: 0-120 hours post dose
Area under the plasma hetrombopag concentration vs time curve (AUC0-inf)
Time frame: 0-infinity
Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)
Time frame: 0-120 hours post dose
Half-life Associated With the Terminal Slope (t½)
Time frame: 0-120 hours post dose
The number of volunteers with adverse events as a measure of safety and tolerability
Time frame: up to Day 22
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Jiangsu HengRui Medicine Co., Ltd.