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.
Approximately 12 subjects will be enrolled in Food Effect clinical trial to conduct an open-label, 2-way crossover treatment study with follow-up period. Twelve subjects will be randomized just prior to dosing to one of the 2 treatment sequences according to a randomization schedule: Sequence 1 is Period 1 Fasted State-Washout -Period 2 Fed State; Sequence 2 is Period 1 Fed State-Washout-Period 2- Fasted State.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Firstly, subjects will receive a fasting administration of F-02-2-Na (50 mg); secondly, a washout period of at least 4 days will be implemented; thirdly, subjects will receive a fed administration of F-02-2-Na (50 mg).
Firstly, subjects will receive a fed administration of F-02-2-Na (50 mg); secondly, a washout period of at least 4 days will be implemented; thirdly, subjects will receive a fasting administration of F-02-2-Na (50 mg).
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Safety Assessment: Adverse Events (AEs) of single orally administered doses of F-02-2-Na in healthy adult subjects
Incidence, severity, and seriousness of adverse events (AEs) of single orally administered doses of F-02-2-Na in healthy adult subjects.
Time frame: 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
Proportion of healthy adult Subjects Using Concomitant Medications during treatment with single orally administered doses of F-02-2-Na.
Time frame: 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
Proportion of healthy adult subjects with abnormal findings in electrocardiogram (ECG) parameters (including PR interval, QRS duration, QT/QTc interval, heart rate, and rhythm) following single orally administered doses of F-02-2-Na.
Time frame: 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
Proportion of healthy adult subjects with clinically significant abnormalities in hematology parameters (e.g., hemoglobin, hematocrit, red blood cell count, white blood cell count with differential, platelet count) following single orally administered doses of F-02-2-Na.
Time frame: 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
Proportion of healthy adult subjects with clinically significant abnormalities in coagulation parameters (e.g., PT, INR, aPTT) following F-02-2-Na.
Time frame: From pre-dose (baseline) to 72 hours after the last dose.
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Proportion of subjects with abnormal urinalysis findings following single orally administered doses of F-02-2-Na
Proportion of healthy adult subjects with clinically significant abnormalities in urinalysis parameters (e.g., protein, glucose, blood, microscopic examination) following single orally administered doses of F-02-2-Na.
Time frame: 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
Proportion of healthy adult subjects with clinically significant abnormalities in clinical chemistry parameters (e.g., sodium, potassium, chloride, calcium, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, BUN, glucose) single orally administered doses of F-02-2-Na.
Time frame: 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
Proportion of healthy adult subjects with abnormal renal morphology as assessed by Renal Color Doppler Ultrasonography (Renal CDU) following single orally administered doses of F-02-2-Na.
Time frame: 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
Proportion of healthy adult subjects with abnormal pelvicalyceal system findings as assessed by Renal Color Doppler Ultrasonography (Renal CDU) following single orally administered doses of F-02-2-Na.
Time frame: 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
Proportion of healthy adult subjects with abnormal renal vascular hemodynamics as assessed by Renal CDU following single orally administered doses of F-02-2-Na.
Time frame: From pre-dose (baseline) to 72 hours post dose
The effect of food on the pharmacokinetic Profile (Cmax) of F-02-2-Na in healthy adult subjects
To determine whether food intake affects key pharmacokinetic parameters: Cmax (maximum plasma concentration) of F-02-2-Na following single oral doses in healthy adult subjects.
Time frame: From pre-dose (baseline) to 72 hours post dose
The effect of food on the Pharmacokinetic Profile: Area Under the Concentration (AUC0-t) of F-02-2-Na in healthy Adult Subjects
To determine whether food intake affects key pharmacokinetic parameters: Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t) of F-02-2-Na following single oral doses in healthy adult subjects.
Time frame: From pre-dose (baseline) to 72 hours post dose
The effect of food on the Pharmacokinetic Profile: Area Under the Concentration (AUC0-∞) of F-02-2-Na in healthy Adult Subjects
To determine whether food intake affects key Pharmacokinetic parameters: Area Under the Concentration-Time Curve from Time 0 to Extrapolated Infinity (AUC0-∞) of F-02-2-Na following single oral doses in healthy adult subjects.
Time frame: From pre-dose (baseline) to 72 hours post dose
The effect of food on the Pharmacokinetic Profile: Time to Maximum Plasma Concentration (Tmax) of F-02-2-Na in healthy Adult Subjects
To determine whether food intake affects key pharmacokinetic parameters: Time to reach maximum plasma concentration (Tmax) of F-02-2-Na following single oral doses in healthy adult subjects.
Time frame: From pre-dose (baseline) to 72 hours post dose
The effect of food on the Pharmacokinetic Profile: Terminal Elimination Half-Life (t1/2) of F-02-2-Na in Adult Subjects
To determine whether food intake affects key pharmacokinetic parameters: Terminal elimination half-life (t1/2) of F-02-2-Na following single oral doses in healthy adult subjects.
Time frame: From pre-dose (baseline) to 72 hours post dose
Absolute Change in Serum Uric Acid (sUA) Levels in healthy Adult Subjects After Single Oral Administrations of F-02-2-Na
To evaluate the absolute change in serum uric acid (sUA) levels in healthy adult subjects after single oral administrations of F-02-2-Na. The absolute change is calculated as the difference between sUA levels at each predefined time point and the baseline sUA level (absolute change = sUA level at predefined time point - baseline sUA level).
Time frame: From pre-dose (baseline) to 72 hours post dose
Percentage Change in Serum Uric Acid (sUA) Levels in healthy Adult Subjects After Single Oral Administrations of F-02-2-Na
To evaluate the percentage change in serum uric acid (sUA) levels in healthy adult subjects after single oral administrations of F-02-2-Na tablets. The percentage change is calculated relative to the baseline sUA level at each predefined time point (percentage change = \[(sUA level at predefined time point - baseline sUA level)/baseline sUA level\] × 100%).
Time frame: From pre-dose (baseline) to 72 hours post dose
Uric Acid Excretion (AeUR) in healthy Adult Subjects After Single Oral Administrations of F-02-2-Na
To evaluate the uric acid excretion (AeUR) in healthy adult subjects after single oral administrations of F-02-2-Na. AeUR is defined as the total amount of uric acid excreted in urine within a specified time period (e.g., 24 hours or predefined intervals after administration), reflecting the cumulative excretion capacity of uric acid.
Time frame: From pre-dose (baseline) to 72 hours post dose
Uric Acid Clearance Rate (CLUR) in healthy Adult Subjects After Single Oral Administrations of F-02-2-Na
To evaluate the uric acid clearance rate (CLUR) in healthy adult subjects after single oral administrations of F-02-2-Na. CLUR is calculated as the ratio of uric acid excretion rate to serum uric acid concentration (CLUR = AeUR / AUC\_sUA), reflecting the efficiency of renal uric acid clearance, with the unit of volume per unit time (e.g., mL/min).
Time frame: From pre-dose (baseline) to 72 hours post dose
Area Under the Curve (AUC) of Serum Uric Acid (sUA) Dynamic Change Curve in healthy Adult Subjects After Single Oral Administrations of F-02-2-Na
To evaluate the area under the curve (AUC) of the serum uric acid (sUA) dynamic change curve in healthy adult subjects after single oral administrations of F-02-2-Na. AUC is calculated by integrating the sUA concentration-time curve over a predefined time period (e.g., AUC₀-t, AUC₀-∞), reflecting the total exposure level of sUA during the observation period, with the unit of concentration × time (e.g., μmol·h/L).
Time frame: From pre-dose (baseline) to 72 hours post dose
Total 24-Hour Uric Acid Excretion in healthy Adult Subjects After Single Oral Administrations of F-02-2-Na
To evaluate the total 24-hour uric acid excretion in healthy adult subjects after single oral administrations of F-02-2-Na. It is determined by collecting 24-hour urine samples, measuring the uric acid concentration in the urine, and calculating the total amount of uric acid excreted in 24 hours (Total 24-hour uric acid excretion = Urine uric acid concentration × 24-hour urine volume), with the unit of mass (e.g., mg/24h or mmol/24h).
Time frame: From pre-dose (baseline) to 72 hours post dose