The study is to evaluate the impact of food on the pharmacokinetics of F-02-2-Na in healthy adult subjects by observing the changes in the drug's pharmacokinetic profile-particularly in its absorption process-before and after food intake.
Age range
18 Years – 45 Years
Sex
ALL
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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.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
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.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Safety Assessment: Adverse Events (AEs) of single orally administered doses of F-02-2-Na in healthy adult subjects
Timeframe: From the start of the first dose to 72 hours after the last dose.
Safety Assessment: Proportion of subjects using Concomitant Medications during single orally administered doses of F-02-2-Na
Timeframe: From the start of the first dose to 72 hours after the last dose.
Safety Assessment: Proportion of subjects with Electrocardiogram (ECG) Findings following single orally administered doses of F-02-2-Na
Timeframe: From pre-dose (baseline) to 72 hours after the last dose.
Proportion of subjects with abnormal hematology findings following single orally administered doses of F-02-2-Na
Timeframe: From pre-dose (baseline) to 72 hours after the last dose.
Proportion of healthy subjects with abnormal coagulation findings following single orally administered doses of F-02-2-Na
Timeframe: From pre-dose (baseline) to 72 hours after the last dose.
Proportion of subjects with abnormal urinalysis findings following single orally administered doses of F-02-2-Na
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Timeframe: From pre-dose (baseline) to 72 hours after the last dose.
Proportion of subjects with abnormal clinical chemistry findings following single orally administered doses of F-02-2-Na
Timeframe: From pre-dose (baseline) to 72 hours after the last dose.
Proportion of subjects with abnormal renal morphology following single orally administered doses of F-02-2-Na
Timeframe: From pre-dose (baseline) to 72 hours post dose
Proportion of subjects with abnormal pelvicalyceal system findings following single orally administered doses of F-02-2-Na
Timeframe: From pre-dose (baseline) to 72 hours post dose
Proportion of subjects with abnormal renal vascular hemodynamics following single orally administered doses of F-02-2-Na
Timeframe: From pre-dose (baseline) to 72 hours post dose