NCT04145583

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Anesthesia
• Sedation

Interventions

Type	Name	Description
DRUG	HSK3486	Sequence 1: Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.
DRUG	voriconazole +HSK3486	Sequence 2: voriconazole：Day 1,400mg，BID；Day 2--Day 6,200mg，BID；200 mg of voriconazole were taken orally in the morning on an empty stomach of Day 7; followed by 1 min intravenous infusion of 0.4 mg/kg HSK3486 30 min later.

Timeline

• Start date: 2019-12-14
• Primary completion: 2020-01-06
• Completion: 2020-05-09
• First posted: 2019-10-30
• Last updated: 2020-12-19

Locations

1 site across 1 country: China