A Phase 1 interventional study of Fuzuloparib in Solid Tumor, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-08.
Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment
The objective of the study is to assess the effect of food on the pharmacokinetics, and safety of Fuzuloparib Capsules in healthy subject.
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:
The first cycle with high-fat meal, the second cycle under fasting.
Drug: Fuzuloparib
The first cycle under fasting, the second cycle with high-fat meal.
Drug: Fuzuloparib
Fuzuloparib Capsules; 150mg; single dose per cycle.
Maximum Plasma Concentration (Cmax)
Time frame: day 1 to day 10
Area under the plasma concentration versus time curve from time 0 to last time of measurable concentration (AUC0-t)
Time frame: day 1 to day 10
Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-∞ )
Time frame: day 1 to day 10
The incidence and severity of adverse events/serious adverse events
Time frame: from ICF signing date to approximate day 23
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jiangsu HengRui Medicine Co., Ltd.