Participants With Moderate Hepatic Impairment

1

Review clinical trials related to Participants With Moderate Hepatic Impairment. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

A Phase I Clinical Trial to Evaluate the Pharmacokinetic and Safety of Ammoxetine Hydrochloride Enteric-Coated Tablets in Participants With Mild Hepatic Impairment, Moderate Hepatic Impairment, and Normal Liver Function

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.

Participants needed: 24
Trial details
Phase: Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Updated: Jul 10, 2026Locations: 1
Eligibility criteria

Adults aged 18 ~ 75 years (inclusive), regardless of gender [+12]

Individuals with a history of allergies (allergic to two or more drugs, foods, o... [+24]