MedTrace Logo

Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Patients With Hepatic Impairment

NCT04145596 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-12-17

No results posted yet for this study

Summary

Comparison of the pharmacokinetics/Pharmacodynamics of the HSK3486 in Patients With Mild and Moderate Hepatic Impairment Compared with Healthy Volunteers

Conditions

  • Hepatic Impairment

Interventions

DRUG

HSK3486

HSK3486，Initially 0.4 mg/kg was administered as a 1 minute bolus, followed immediately by a constant infusion dose of 0.4 mg/kg/h administered as a 30 minute infusion via infusion pump.

Sponsors & Collaborators

  • The First Hospital of Jilin University

    collaborator OTHER

  • Sichuan Haisco Pharmaceutical Group Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Yan-hua Ding, PhD · Phase I Clinical Trial Laboratory，The First Hospital of Jilin University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-14
Primary Completion
2020-04-20
Completion
2020-07-13

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04145596 on ClinicalTrials.gov