Condition: Healthy Participants · Participants With Mild Hepatic Impairment · Participants With Moderate Hepatic Impairment · Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Use these resources to provide understandable information about this study to patients, families, and health care providers:This study is a multi-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 mild hepatic impairment (Child-Pugh Class A), moderate hepatic impairment (Child-Pugh Class B), and participants with normal liver function who are matched for age, weight, and gender. Participants in all groups receive 20 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, 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.
Clinical Trials Information Group officer · 031169085587 · ctr-contact@cspc.cn
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| The First Affiliated Hospital of Soochow University | Suzhou, Jiangsu, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07694843