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RECRUITING
NCT07174830
PHASE4

Pharmacokinetic Study of Allisartan Isoproxil Tablets in Healthy Chinese Participants

Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2025-09-06

Completion Date

2026-02-16

Last Updated

2025-09-16

Healthy Volunteers

Yes

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

Locations (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, China