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A Study Evaluating Drug-Drug Interaction (DDI) Between HSK3486 Injectable Emulsion and Voriconazole Tablets

Anesthesia Clinical Trial

Official title:
A Single-Center, Open-Label, Randomized, Two-Stage, and Two-Way Crossover Study Evaluating Drug-Drug Interaction (DDI) Between HSK3486 Injectable Emulsion and Voriconazole Tablets in Healthy Subjects

Clinical Trial Summary

This is a single-center, open-label, randomized, two-stage, two-way crossover study evaluating the effect of voriconazole on the PK, PD, and safety of HSK3486 in healthy subjects.

Clinical Trial Description

After the recruited healthy subjects passed the screening of inclusion and exclusion criteria, a seed number was set in the PLAN program of the SAS 9.4 software by the statistician before the formal enrollment, and the subject screening numbers were randomly assigned to the two groups by using a 1:1 block randomization method. The enrolled subjects were assigned a subject number according to the results of randomization and received stage I dosing of HSK3486 injectable emulsion (sequence 1) or HSK3486 injectable emulsion + voriconazole (sequence 2). After a 7-day (sequence 1) or 14-day washout period (sequence 2), the stage II dosing of HSK3486 injectable emulsion + voriconazole (sequence 2) or HSK3486 injectable emulsion (sequence 1) was carried out in a crossover fashion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04145583
Study type Interventional
Source Haisco Pharmaceutical Group Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date December 14, 2019
Completion date May 9, 2020
View Details
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