This is a randomized, double-blind, placebo-controlled, dose-escalation study in healthy Chinese subjects at single dose administration of Allisartan Isoproxil Tablets (240 mg ,480 mg or 720 mg）or placebo. The study design allows an assessment of 3 doses with safety monitoring and PK sampling to evaluate the safety, tolerability and PK profile of Allisartan Isoproxil Tablets.
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 25.0 kg/m2.
Seated systolic blood pressure (SBP) ≥100 mmHg and <140 mmHg, seated diastolic blood pressure (DBP) ≥70 mmHg and <90 mmHg, and no orthostatic hypotension at screening.
Participants must be able to communicate effectively with the investigator, fully understand the trial's objectives and requirements, voluntarily participate in the clinical trial, and provide written informed consent.
Known or suspected allergy to Allisartan Isoproxil, , other ARBs, or any excipients of this formulation.
Abnormal findings in physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that are clinically significant as judged by the investigator.
Any medical history or current condition that may impact participant safety assessments or the pharmacokinetics of the investigational drug, including but not limited to disorders of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematologic system, immune system, psychiatric conditions, metabolic abnormalities, or prior gastrointestinal surgery.
Used any prescription drugs, over-the-counter medications,Chinese herbal medicines, or food supplements within 14 days prior to screening.
Parallel
Allisartan Isoproxil Tablets 240mg or placebo
DrugAllisartan Isoproxil Tablets 240mg or placebo, QD
Allisartan Isoproxil Tablets 480mg or placebo
DrugAllisartan Isoproxil Tablets 480mg or placebo, QD
Allisartan Isoproxil Tablets 720mg or placebo
DrugAllisartan Isoproxil Tablets 720mg or placebo, QD
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent adverse events during the whole study
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)
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