NCT01657201

Study to Evaluate the Pharmacokinetic Properties of SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend)

A Randomized, Open-label, Two-Treatment, Two-Period, Two-Sequence, Cross-over Study to Evaluate the Pharmacokinetic Properties of SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend) in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Samyang Biopharmaceuticals Corporation · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetic properties and safety of SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend).

Conditions

• Systemic Mycotic Infection

Interventions

Type	Name	Description
DRUG	SYP-1018 200mg	SYP-1018 200mg, Intravenous administration
DRUG	Voriconazole 200mg	Voriconazole 200mg, Intravenous administration

Timeline

• Start date: 2012-09-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-08-06
• Last updated: 2012-12-24

Locations

1 site across 1 country: South Korea