A Pharmacokinetic Study of the Food Effect on Flonoltinib Maleate Tablets (NCT07193576) | Clinical Trial Compass
CompletedPhase 1
A Pharmacokinetic Study of the Food Effect on Flonoltinib Maleate Tablets
China24 participantsStarted 2024-08-04
Plain-language summary
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
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18 to 45 years old (including 18 and 45 years old), gender is not limited;
. Male subjects weighing ≥50.0 kg, female subjects ≥45.0 kg, with body mass index (BMI) between 19.0 and 25.0 kg/m2 (including borderline values);
. Fully understand the content of the trial, the test drug, the trial process, etc, and be able to communicate well with the researcher, willing to comply with the study regulations, participate in the trial voluntarily and sign an Inform consent.
Exclusion criteria
. Those with a history of severe allergies (e.g, angioedema and anaphylaxis), allergies (Screening Consultation/Admission Consultation) Those with a history of severe allergy (e.g, angioedema and anaphylaxis), allergy (e.g, allergy to pollen, two or more medications/foods), or history of food or drug allergy or other metabolic disorders (e.g, asthma, hives, eczematous dermatitis, etc.) judged by the investigator to be clinically significant, or a known allergy to JAK inhibitors or an allergy to excipient components of the test medication;
. Abnormal and clinically significant results of physical examination, vital signs, 12-lead electrocardiogram, laboratory tests (including routine blood, blood biochemistry, urine routine, blood pregnancy (only for women of childbearing age), infectious disease screening, antinuclear antibody, coagulation function, tuberculosis antibody, chest X-ray, abdominal ultrasound) prior to enrolment;
. QTcF \> 440 ms for males and \> 460 ms for females on ECG during the screening period;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cmax
Timeframe: 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
2
AUC0-t
Timeframe: 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
3
AUC0-∞
Timeframe: 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
4
Tmax
Timeframe: 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
5
t1/2
Timeframe: 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
. Those who have undergone major surgical procedures within 3 months prior to screening or plan to undergo surgery during the trial period;
. Acute illness within 2 weeks prior to screening; clinically significant infection (e.g, upper respiratory tract infection, nasopharyngitis, urinary tract infection, etc.) within 3 months prior to screening; evidence of any infection within 7 days prior to screening; history of herpes simplex infection, or recurrent (\>once) herpes zoster or disseminated herpes zoster;
. History of any clinically serious disease or any disease or condition that, in the opinion of the investigator, may affect the outcome of the trial, including but not limited to a history of circulatory, endocrine, neurological, gastrointestinal, urinary, or haematological, immunological, psychiatric, and metabolic disorders;
. Dysphagia or any history of gastrointestinal disorders (or gastrointestinal resection, etc.) affecting drug absorption; 8 . Those with irregular bowel movements and habitual constipation or diarrhoea;
tlag
Timeframe: 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
7
CL/F
Timeframe: 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
8
Vd/F
Timeframe: 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
9
λz
Timeframe: 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
10
%AUCex
Timeframe: 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