Pharmacokinetic Study of Allisartan Isoproxil Tablets in Healthy Chinese Participants

Recruiting Phase 4 Interventional Study
Healthy Participants
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
54 (estimated)
Sponsor
Shenzhen Salubris Pharmaceuticals Co., Ltd. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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,…
Contacts

Hongying Yang, M.D.

0755-22942636

yanghy0119@163.com

CONTACT