Evaluation of the pharmacokinetics of Hemay 5259 sustained-release tablets in healthy human subjects
Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
Adult males and females between ≥ 18 and ≤ 55 years (inclusive) at Screening.
Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 with a body weight ≥ 50 kg (males) or ≥45 kg (females) at Screening.
Participants with normal results or non-clinically significant (NCS) abnormal results in the opinion of the PI or delegate for a comprehensive examination, including physical examination, vital signs examination, laboratory tests (hematology, biochemistry, coagulation and urinalysis).
Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, musculoskeletal, rheumatological, psychiatric , systemic, ocular, or infectious disease, or signs of acute illness.
Any history or presence of depression.
Any history or presence of gastrointestinal, hepatic, renal disease that affect drug absorption or metabolism.
Any surgery within 1 months prior to the first dose.