NCT07345689

A Study of the Pharmacokinetics and Safety of Anaprazole Sodium in Special Populations

A Study to Evaluate the Pharmacokinetics and Safety of Anaprazole Sodium in Subjects With Hepatic or Renal Impairment and in Elderly Subjects

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Xuanzhu Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the pharmacokinetic profile and safety of anaprazole sodium in adult subjects, particularly including the elderly and those with renal or hepatic impairment.

Detailed description

This study is a single-center, open-label, single-dose trial designed to assess the pharmacokinetics and safety of anaprazole sodium in adult subjects. The study consists of five groups: healthy volunteers, subjects with moderate hepatic impairment, subjects with moderate renal impairment, subjects with severe renal impairment, and elderly subjects. Each arm will enroll 8-12 subjects, for a total target sample size of 40-60. The overall trial schedule consists of a Screening Period (Day -14 to Day -2), a Baseline Period (Day -1), a Dosing/Study Period (Day 1 to Day 3), and a Safety Follow-up Period (Day 7). Blood samples for pharmacokinetic (PK) analysis will be collected from all subjects throughout the study. In addition, urine samples for PK assessment will be collected specifically from subjects in the healthy control group and the moderate and severe renal impairment groups.

Conditions

• Hepatic Insufficiency
• Renal Insufficiency
• Elderly

Interventions

Type	Name	Description
DRUG	Anaprazole Sodium enteric-coated tablet	20 mg single dose

Timeline

• Start date: 2026-01-30
• Primary completion: 2026-10-30
• Completion: 2027-06-30
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: China