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Comparative Study on Tolerance and Pharmacokinetics of Voriconazole for Injection in Healthy Subjects

NCT05330000 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-04-15

No results posted yet for this study

Summary

A single intravenous drip of voriconazole for injection developed by Qilu Pharmaceutical (Hainan) Co., Ltd. and the original product "vfend" was given to healthy subjects ， The pharmacokinetic differences and tolerance of the two preparations were evaluated at the doses of 4mg / kg and 6mg / kg.

Conditions

  • Healthy Adults

Interventions

DRUG

4 mg/kg Voriconazole

Low dose group: 24 healthy adult subjects are planned to be enrolled. Intravenous drip Voriconazole for injection in fasting state per cycle. The dosage was 4 mg / kg for 80 min.

DRUG

6 mg/kg Voriconazole

High dose group: 24 healthy adult subjects are planned to be enrolled. Intravenous drip Voriconazole for injection in fasting state per cycle. The dosage was 6 mg / kg for 120 min.

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Principal Investigators

  • Yu Cao, Doctor · National Medical Products Administration

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-05-22
Primary Completion
2020-07-08
Completion
2020-09-16

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 NCT05330000 on ClinicalTrials.gov