MedTrace Logo

Pharmacokinetic Study of Allisartan Isoproxil Tablets in Healthy Chinese Participants

NCT07174830 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-09-16

No results posted yet for this study

Summary

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

  • Healthy Participants

Interventions

DRUG

Allisartan Isoproxil Tablets 240mg or placebo

Allisartan Isoproxil Tablets 240mg or placebo, QD

DRUG

Allisartan Isoproxil Tablets 480mg or placebo

Allisartan Isoproxil Tablets 480mg or placebo, QD

DRUG

Allisartan Isoproxil Tablets 720mg or placebo

Allisartan Isoproxil Tablets 720mg or placebo, QD

Sponsors & Collaborators

  • Shenzhen Salubris Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hongying Yang, M.D. · Shenzhen People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-06
Primary Completion
2025-12-31
Completion
2026-02-16

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07174830 on ClinicalTrials.gov