Subjects
Inclusion criteria for this study included the following: healthy
subjects must be 18 years of age or older (including 18 years of age).
Volunteers had a body mass index (BMI) of 19.0-26.0
kg/m2 (BMI = weight
[kg]/height2[m2]) and
weighed no less than 50 kg for men and 45 kg for women.
Exclusion criteria included: allergy to the study drug, smoking, alcohol
abuse, and use of CYP-modifying drugs within 30 days before the trial;
the presence of clinically significant abnormalities in the results of
physical examination, vital sign monitoring, electrocardiogram
examination, and laboratory tests including routine blood, urine, and
blood biochemistry performed during the screening period, which was
judged by the investigator to be clinically significant; the presence of
clinically significant cardiovascular, hepatic, renal, endocrine
digestive tract, hematological system, respiratory system, psychiatric
abnormalities, or existing diseases of the above systems; those with
positive hepatitis B surface antigen, or positive hepatitis C antibody,
or positive syphilis spirochete antibody, or positive HIV antibody test.
In addition, subjects must not have participated in another clinical
study within 90 days before the start of this study. Before any study
procedures, all participants provided written informed consent after
being informed by the clinical investigator of the purpose, nature,
procedures, and any risks of the
study.