A Phase 1 interventional study of flunotinib in Heathly Subjects, sponsored by Chengdu Zenitar Biomedical Technology 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 2025-09-26.
Sponsored by Chengdu Zenitar Biomedical Technology Co., Ltd · Phase 1, Interventional, and Other
A Randomized, Open-Label, Two-Period, Two-Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Flonoltinib Maleate Tablets in Healthy Subjects Under Fed Conditions
Primary Study Objective. To evaluate the effect of a high-fat diet on the pharmacokinetics of single-dose oral Flonoltinib Maleate tablets in healthy subjects.
Secondary Study Objectives To evaluate the safety of single-dose oral administration of Flonoltinib Maleate Tablets under Fast or Fed condition in healthy subjects.
Chengdu Zenitar Biomedical Technology Co., Ltd is the lead sponsor of 23 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
9. Those with a history of lipid metabolism defects, such as: familial hyperlipidaemia, lipoid nephropathy, or patients with acute pancreatitis accompanied by hyperlipidaemia; 10. Those with a positive combined urine multi-drug test (including morphine, methamphetamine, ketamine, methylenedioxyamphetamine, tetrahydrocannabinolic acid); 11. Those with a history of previous drug abuse or drug dependence; 12. Anyone who has been vaccinated within 8 weeks prior to screening or who plan to be vaccinated during the course of the study or within 8 weeks of administration of study drug; 13. Anyone who has donated or lost ≥400 mL of blood or received a blood transfusion within 3 months prior to screening; or anyone who has donated blood or blood components within 1 month of the planned end of the trial; 14. Those with special dietary requirements or those who are unable to comply with the uniform dietary and appropriate regulations of the study center; 15. Those who have smoked more than 3 cigarettes/day or equivalent amount of tobacco in the 3 months prior to screening; or who have consumed ≥14 units of alcohol per week (1 unit equals to 17.5mL or 14g of pure alcohol, which is approximately equal to 35mL of 50° white wine or 350mL of 5° beer); or who do not agree to abstain from smoking or drinking alcohol for the duration of the trial; or those who have a positive result from an alcohol breathalyzer test; 16. Any person who has taken any prescription drug, over-the-counter drug, any vitamin product or herbal medicine (JAK inhibitor, immunosuppressant, etc.) within 14 days prior to screening; 17. Those who have combined strong inducers of liver metabolism enzymes (e.g, omeprazole, barbiturates, carbamazepine, amiloride, pallidomycin, aminoglutethimide, phenytoin, grumet, rifampicin, sulfinpyrazone, roxithromycin, etc.) within the 4 weeks (28 days) prior to Screening, or any other history of medication use that in the judgement of the Investigator has the potential to interfere with in vivo pharmacokinetics of the test drug. Anyone who has taken any drug known to cause prolongation of the QT/QTcF interval or a drug with a risk of causing torsades de pointes (TdP) within 4 weeks (28 days) prior to Screening; or drugs with a long half-life; 18. Anyone who consumed any food or drink containing caffeine (e.g. coffee, strong tea, cola, chocolate, etc.) or food containing grapefruit juice that may have an effect on metabolising enzymes or who consumed food or drink containing alcohol within 48 h prior to the administration of the drug; 19. Those who are participating in other clinical trials and have used an investigational drug, vaccine or device within 3 months prior to the first dose; 20. Pregnant or breastfeeding women or women of childbearing age who have had unprotected sex within 14 days prior to screening; 21. The subject or his/her partner is unwilling to use non-pharmacological contraception (e.g, total abstinence, condom, IUD, ligation, etc.) for contraception during the trial period or the subject and/or his/her partner has a pregnancy plan within 3 months of the administration of the study drug; 22. The subject may not be able to complete the study for other reasons or there are other factors that, in the opinion of the investigator, make participation in the trial unsuitable.
Subjects received Flonoltinib Maleate: under fast condition → washout → under fed condition
Drug: flunotinib
Subjects received Flonoltinib Maleate: under fed condition → washout → under fast condition
Drug: flunotinib
100mg
Cmax
maximum concentration
Time frame: Day1 and Day11 Within 2hours before administration and 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12hours, 24hours, 48 hours, 72 hours, 96 hours, 120hours, 144 hours after administration
AUC0-t
Area under the blood concentration-time curve from 0 o 'clock to the last measurable concentration at collection time t
Time frame: Day1 and Day11 Within 2 hours before administration and 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12hours, 24hours, 48 hours, 72 hours, 96 hours, 120hours, 144 hours after administration
AUC0-∞
The area under the blood drug concentration-time curve from 0 to infinity time
Time frame: Day1 and Day11 Within 2 hours before administration and 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12hours, 24hours, 48 hours, 72 hours, 96 hours, 120hours, 144 hours after administration
Tmax
time to peak
Time frame: Day1 and Day11 Within 2 hours before administration and 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12hours, 24hours, 48 hours, 72 hours, 96 hours, 120hours, 144 hours after administration
t1/2
Terminal phase elimination half-life
Time frame: Day1 and Day11 Within 2 hours before administration and 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12hours, 24hours, 48 hours, 72 hours, 96 hours, 120hours, 144 hours after administration
tlag
retardation time
Time frame: Day1 and Day11 Within 2 hours before administration and 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12hours, 24hours, 48 hours, 72 hours, 96 hours, 120hours, 144 hours after administration
CL/F
apparent clearance
Time frame: Day1 and Day11 Within 2 hours before administration and 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12hours, 24hours, 48 hours, 72 hours, 96 hours, 120hours, 144 hours after administration
Vd/F
apparent volume of distribution
Time frame: Day1 and Day11 Within 2 hours before administration and 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12hours, 24hours, 48 hours, 72 hours, 96 hours, 120hours, 144 hours after administration
λz
Terminal elimination rate constant
Time frame: Day1 and Day11 Within 2 hours before administration and 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12hours, 24hours, 48 hours, 72 hours, 96 hours, 120hours, 144 hours after administration
%AUCex
The extrapolation percentage of AUC0--∞
Time frame: Day1 and Day11 Within 2 hours before administration and 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12hours, 24hours, 48 hours, 72 hours, 96 hours, 120hours, 144 hours after administration
health checkup
General examination
Time frame: Screening period, day 17 or early withdrawal
participants with abnormal vital signs
Temperature
Time frame: Screening period,Day1to day7 and day11 to day17
participants with abnormal laboratory tests results
White blood cell count
Time frame: Screening period, Day-1 (examination results within 7 days are acceptable), Day17, or early withdrawal
participants with abnormal laboratory tests results
creatinine
Time frame: Screening period, Day-1 (examination results within 7 days are acceptable), Day17, or early withdrawal
participants with abnormal laboratory tests results
Blood pregnancy test,Only for women of childbearing age
Time frame: Screening period, Day-1 ,Day 10,Day 17 or early termination
Urinary albumin creatinine ratio
Urinary albumin creatinine ratio
Time frame: D-1, D17 or early termination
ECG QT Interv
12-lead electrocardiogram
Time frame: Screening period, Day-1 ,Day1, Day10, Day11, Day17 or early termination
participants with abnormal vital signs
blood pressure
Time frame: Screening period,Day1to day7 and day11 to day17
participants with abnormal laboratory tests results
neutrophil count
Time frame: Screening period, Day-1 (examination results within 7 days are acceptable), Day17, or early withdrawal
participants with abnormal laboratory tests results
hemoglobin
Time frame: Screening period, Day-1 (examination results within 7 days are acceptable), Day17, or early withdrawal
participants with abnormal laboratory tests results
platelet coun
Time frame: Screening period, Day-1 (examination results within 7 days are acceptable), Day17, or early withdrawal
participants with abnormal laboratory tests results
red blood cell count
Time frame: Screening period, Day-1 (examination results within 7 days are acceptable), Day17, or early withdrawal
participants with abnormal laboratory tests results
alanine aminotransferase
Time frame: Screening period, D-1 (examination results within 7 days are acceptable), Day17, or early withdrawal
participants with abnormal laboratory tests results
aspartate aminotransferase
Time frame: Screening period, D-1 (examination results within 7 days are acceptable), Day17, or early withdrawal
participants with abnormal laboratory tests results
total bilirubin
Time frame: Screening period, Day-1 (examination results within 7 days are acceptable), Day17, or early withdrawal
participants with abnormal laboratory tests results
direct bilirubin
Time frame: Screening period, Day-1 (examination results within 7 days are acceptable), Day17, or early withdrawal
participants with abnormal laboratory tests results
γ-glutamyl transpeptidase
Time frame: Screening period, Day-1 (examination results within 7 days are acceptable), Day17, or early withdrawal
participants with abnormal laboratory tests results
Alkaline phosphatase
Time frame: Screening period, Day-1 (examination results within 7 days are acceptable), Day17, or early withdrawal
participants with abnormal laboratory tests results
triglycerides
Time frame: Screening period, Day-1 (examination results within 7 days are acceptable), Day17, or early withdrawal
participants with abnormal laboratory tests results
total cholesterol
Time frame: Screening period, Day-1 (examination results within 7 days are acceptable), Day17, or early withdrawal
adverse event
Adverse events, serious adverse events, suspected and unexpected serious adverse reactions (SUSAR), priority adverse reactions, incidence of adverse reactions
Time frame: From date of randomization until the date of completion of data collection, assessed up to 17 days or early termination
participants with abnormal urinalysis
Acidity/Alkalinity
Time frame: Screening period, Day-1 , Day17, or early withdrawal
participants with abnormal urinalysis
Red Blood Cells
Time frame: Screening period, Day-1 , Day17, or early withdrawal
participants with abnormal urinalysis
White Blood Cells
Time frame: Screening period, Day-1 , Day17, or early withdrawal
participants with abnormal urinalysis
Protein
Time frame: Screening period, Day-1 , Day17, or early withdrawal
participants with abnormal urinalysis
Glucose
Time frame: Screening period, Day-1 , Day17, or early withdrawal
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2025. 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.
Chengdu Zenitar Biomedical Technology Co., Ltd