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.
1. The subjects should fully understand the purpose, nature, process of the study and the possible adverse reactions, voluntarily act as subjects, and sign the informed consent form before the start of any research procedures.
2. Healthy male or female subjects aged 18 to 45 years old (inclusive).
3. The body weight for male and female subjects should be ≥ 50.0 kg and ≥ 45.0 kg, respectively; the body mass index (BMI) should be between 19 kg/m² and 26 kg/m² (inclusive).
4. The subjects should have normal results or abnormal results without clinical significance in vital signs check, physical examination, clinical laboratory tests (Complete Blood Count (CBC), urine analysis, blood biochemistry, coagulation panel, free thyroid function tests), chest X-ray, liver and renal color ultrasound and 12-lead electrocardiogram.
1. Subjects with a specific allergic history (such as asthma, urticaria, eczema, etc.) or those with an allergic constitution (such as those known to be allergic to two or more substances), or those with a known history of allergy to F-02-2-Na and related excipients (ascertained through inquiry).
2. Subjects who have had an acute illness within two weeks before the first drug administration (ascertained through inquiry).
3. Subjects with diseases of important organs or systems (including but not limited to liver, kidney, nervous system, blood, endocrine system, lungs, immune system, mental health, cardiovascular and cerebrovascular system, gastrointestinal tract, skin, metabolism, bone and joints, etc.) that are considered clinically significant by the researcher, or those with a history of such serious diseases; or those with a history of tumor (ascertained through inquiry).
4. Subjects with a history of gastrointestinal, liver, kidney, and thyroid diseases that can affect drug absorption or metabolism (ascertained through inquiry).
Crossover
Fasting administration of F-02-2-Na (50mg) - Fed administration of F-02-2-Na (50mg)
DrugFirstly, 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).
Fed administration of F-02-2-Na (50mg) - Fasting administration of F-02-2-Na (50mg)
DrugFirstly, 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).
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.
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.
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.
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.
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.
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.
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.
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.
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Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd.
Lead sponsor
Xiangbei Welman Pharmaceutical Co., Ltd
Collaborator
Guangzhou Xin-Chuangyi Biopharmaceutical Co., Ltd.
Collaborator
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