Clinical Trial

A Phase I Clinical Trial to Evaluate the Pharmacokinetic Characteristics of Ammoxetine Hydrochloride Enteric-Coated Tablets in Participants With Moderate Renal Impairment and Normal Renal Function

Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
This study is a single-center, non-randomized, open-label, parallel-group, multiple-dose Phase I clinical trial evaluating the pharmacokinetic characteristics of ammoxetine hydrochloride enteric-coated tablets in participants with normal renal function and moderate renal impairment. The study enrolls 16 participants divided into two groups: Group A (participants with normal renal function) and Group B (participants with moderate renal impairment). Participants in both groups receive 60 mg of ammoxetine hydrochloride enteric-coated tablets daily at 1 hour after meals, from day 1 to day 6. Blood samples for pharmacokinetic (PK) analysis, urine samples, and safety parameters are collected before and after dosing according to the trial protocol.
Trial Details
NCT Number NCT07694869
Lead Sponsor CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions Healthy Participants, Participants With Moderate Renal Impairment
Enrollment 16 participants
Start Date 2026-05-10
Primary Completion 2026-10-10 (estimated)
Study Completion 2026-11-11 (estimated)
Updated on ClinicalTrials.gov 2026-07-10