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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Samyang Biopharmaceuticals Corporation
• Treatments: Voriconazole

Criteria

Inclusion Criteria:

• Healthy adults 20-45 years of age

• Weight of ≥ 60kg ≤ 90kg with BMI of ≥ 19 and < 27 (BMI(kg/m2)= weight(kg)/{height(m)}2

• Voluntary written informed consent

Exclusion Criteria:

• History or presence of significant renal, neurologic, pulmonary, endocrine, hematology, oncology, urologic, cardiovascular, musculoskeletal or psychiatric disease

• Drug allergies to Voriconazole

• Recent history or evidence of drug abuse

• Recent participation(within 2 months) in other clinical studies

• Recent donation of blood(within 2months), plasma(within 1month) or transfusion(within 1month)