Actively Recruiting
Pharmacokinetic Study of Allisartan Isoproxil Tablets in Healthy Chinese Participants
Led by Shenzhen Salubris Pharmaceuticals Co., Ltd. · Updated on 2025-09-16
54
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pharmacokinetic Study of Allisartan Isoproxil Tablets in Healthy Chinese Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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 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
- Participants with hyponatremia, hyperkalemia, or hypovolemia
- Participants with a history of orthostatic hypotension or syncope
- Participants who have received any vaccinations within 4 weeks prior to screening
- Participants who consume excessive amounts of strong tea, coffee, and/or caffeinated beverages (8 cups/day), or have consumed such beverages within 48 hours prior to dosing, or cannot abstain during the trial
- Participants with habitual intake of xanthine-rich or grapefruit-containing products, or have consumed such products within 48 hours prior to dosing, or cannot abstain during the trial
- Female participants who are pregnant or breastfeeding
- Participants (or their partners/spouses) who plan pregnancy, sperm/egg donation, or refuse to use at least one acceptable contraceptive method during the trial and for 3 months post-study
- Participants with a positive result for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or treponema pallidum antibody tests
- Heavy smokers or participants with an average tobacco consumption of more than 5 cigarettes per day within 3 months prior to screening, or those who could not completely stop consuming tobacco products during the study
- Heavy drinkers or participants with an average alcohol consumption of more than 14 units per week within 3 months prior to screening, or with a positive breath alcohol test at screening, or those who could not completely stop consuming alcohol during the study
- Participants with a positive result for drug abuse test at screening, a history of drug abuse in the past 5 years, or recent illicit drug use within 3 months prior to screening
- Participants who have participated in other drug/device trials and received investigational products within 3 months prior to screening
- Participants who have donated blood (400 mL), received transfusions, or used blood products within 3 months prior to screening
- Participants with difficult venous access or intolerance to repeated venipuncture
- Participants with difficulty swallowing study medication
- Participants deemed by investigators to have poor compliance or other factors unsuitable for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Actively Recruiting
Research Team
H
Hongying Yang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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