NCT05330000

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Low dose group: 24 healthy adult subjects are planned to be enrolled. Intravenous drip Voriconazole (T) for injection or reference preparation vfend ® (R) in fasting state per cycle. The dosage was 4 mg / kg for 80 min;After a 7-day cleaning period, the second cycle of cross administration. High dose group: 24 healthy adult subjects are planned to be enrolled. Intravenous drip Voriconazole (T) for injection or reference preparation vfend ® (R) in fasting state per cycle. The dosage was 6 mg / kg for 120 min;After a 7-day cleaning period, the second cycle of cross administration.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-05-22
• Primary completion: 2020-07-08
• Completion: 2020-09-16
• First posted: 2022-04-15
• Last updated: 2022-04-15

Locations

1 site across 1 country: China