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

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.

Timeline

Start

2026-05-10

Primary completion

2026-10-10

Completion

2026-11-11

Drugs

Indications

No indication recorded.