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).
Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd.
Lead sponsor
Xiangbei Welman Pharmaceutical Co., Ltd
Collaborator
Guangzhou Xin-Chuangyi Biopharmaceutical Co., Ltd.
Collaborator