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

NCT04145583 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-12-19

No results posted yet for this study

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.

Conditions

  • Anesthesia
  • Sedation

Interventions

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.

Sponsors & Collaborators

  • Sichuan Haisco Pharmaceutical Group Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Liyan Miao, PhD · Medical Ethics Committee of the First Affiliated Hospital of soochow University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-12-14
Primary Completion
2020-01-06
Completion
2020-05-09

Countries

  • China

Study Locations

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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 NCT04145583 on ClinicalTrials.gov