This is a single-center, double-blind study to evaluate the safety, tolerability, pharmacokinetics of Gastrodin Injection in healthy Subjects
Subjects must have a full understanding of the trial's purpose, nature, procedures, and potential adverse reactions, voluntarily consent to participate as subjects, sign the informed consent form prior to the initiation of any research procedures, be capable of effective communication with investigators, and understand and comply with all requirements of the study.
Healthy male or female subjects aged 18 to 65 years (inclusive of boundary values), with a male-to-female ratio of 1:1.
Male subjects with a body weight ≥ 50.0 kg and female subjects with a body weight ≥ 45.0 kg. body mass index (BMI) ranging from 19.0 to 26.0 kg/m² (inclusive of boundary values) .
Subjects must have no fertility plans during the trial period and within 3 months after the final administration, voluntarily adopt effective contraceptive measures, and have no plans to donate sperm or eggs.
Subjects who developed acute diseases within 2 weeks prior to screening, such as acute gastroenteritis, acute upper respiratory tract infection, acute appendicitis, etc.
Subjects with a history of any clinically severe diseases or conditions that the investigator deems may interfere with the evaluation of the safety or pharmacokinetic properties of the investigational drug, including but not limited to diseases of the circulatory, respiratory, endocrine, nervous, digestive, urinary systems, as well as hematological, immunological, psychiatric, and metabolic diseases.
Subjects who underwent major surgery within 6 months prior to screening, or plan to undergo surgery during the study period or within 1 month after the trial completion.
Subjects with an allergic diathesis (known hypersensitivity to two or more drugs) or known hypersensitivity to Gastrodin Injection and its related excipients.
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Treatment groupsSee each treatment group below.