NCT07174830

Pharmacokinetic Study of Allisartan Isoproxil Tablets in Healthy Chinese Participants

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will be conducted at 1 study center in Shenzhen. 18 healthy Chinese male and female participants per group, aged 18 to 65 inclusive, will be randomized in a 5:1 ratio to receive a single administration of Allisartan Isoproxil Tablets (240 mg ,480 mg or 720 mg）or placebo (54 participants in total). Each participant will participate in only 1 treatment group. Blood samples will be collected up to 72 hours post-dose for pharmacokinetic parameter calculation, and safety monitoring will continue until sample collection is complete.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-09-06
• Primary completion: 2025-12-31
• Completion: 2026-02-16
• First posted: 2025-09-16
• Last updated: 2025-09-16

Locations

1 site across 1 country: China