The purpose of this study is to evaluate the bioequivalence of the test preparation (Fluvastatin sodium extended release tablet, 80 mg) manufactured by Shenzhen Salubris Pharmaceuticals Co., Ltd. and the reference preparation (80 mg) manufactured by Beijing Novartis Pharma Co., Ltd. in healthy participants under fasting and fed conditions.
Participants have fully understood the trial's objectives, procedures, and potential adverse effects, and voluntarily signed informed consent form prior to the trial.
Participants are able to communicate effectively with the investigator and comply with the protocol requirements to complete the trial.
Healthy male or female adults aged 18 to 65 years (inclusive).
Body weight ≥50 kg for male participants and ≥45 kg for female participants at screening, with a body mass index (BMI) between 19.0 and 26.0 kg/m2 (inclusive; BMI = body weight ÷ height2).
Pregnant or lactating women, or women of child-bearing potential (WOCBP) with a positive pregnancy test at screening.
Participants who have a history of clinically significant acute allergy to drug or food within two weeks prior to screening, or have an allergic constitution (e.g., allergy to two or more drugs, food, or pollens), or have a history of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.), or have possible or definite allergy, hypersensitivity or clinically significant reactions to investigational drugs or excipients judged by the investigator.
Participants with any disease (e.g., acute gastritis, peptic ulcer, anaphylactoid purpura, lupus erythematosus, etc.) or history (e.g., haemorrhage intracranial, hemorrhage intraocular, haemophilia, angiohaemophilia, etc.) that may change or aggravate haemorrhagic diathesis as judged by the investigator.
Participants with a positive result for any of the following tests: hepatitis B surface antigen test, hepatitis C antibody test, HIV antibody test, and treponema pallidum antibody test.
Crossover
Group A
DrugDrug: Fluvastatin sodium extended release tablet, 80 mg Period 1 and 3, the participants randomly received single oral dose of test drug ( Fluvastatin sodium extended release tablet 80 mg). Period 2 and 4, the participants randomly received single oral dose of reference drug ( Fluvastatin sodium extended release tablet 80 mg).
Reference Group
DrugDrug: Fluvastatin sodium extended release tablet, 80 mg Period 1 and 3, the participants randomly received single oral dose of reference drug ( Fluvastatin sodium extended release tablet 80 mg). Period 2 and 4, the participants randomly received single oral dose of test drug ( Fluvastatin sodium extended release tablet 80 mg).
Cmax
Observed maximum plasma concentration (Cmax)
AUC0-t
Plasma concentration-time curve from time zero extrapolated to the time of last quantifiable concentration (AUC0-t)
AUC0-∞
Plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
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