NCT04142970

Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Patients With Impairment Renal Functions

A Clinical Study Comparatively Evaluating the Pharmacokinetics, Pharmacodynamics and Safety of Intravenous Administration of HSK3486 Injectable Emulsion in Patients With Chronic Renal Impairment and Subjects With Normal Renal Functions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

A Clinical Study Comparatively Evaluating the Pharmacokinetics, Pharmacodynamics and Safety of Intravenous Administration of HSK3486 Injectable Emulsion in Patients with Chronic Renal Impairment and Subjects with Normal Renal Functions

Detailed description

This is a single-center, open-label, non-randomized, parallel-controlled Phase I clinical study carried out in subjects with varying degrees (mild or moderate) of renal impairment, and age-, weight-, and gender-matched subjects with normal renal functions.

Conditions

• Chronic Renal Impairment

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-01-05
• Primary completion: 2020-08-04
• Completion: 2020-08-18
• First posted: 2019-10-29
• Last updated: 2020-12-19

Locations

1 site across 1 country: China