Condition: Healthy Participants · Participants With Moderate Renal Impairment · Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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.
This description comes directly from the study's public registry record.
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| The First Affiliated Hospital of Anhui Medical University | Hefei, Anhui, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07694869