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

Samyang Biopharmaceuticals Corporation

Status and phase: Completed; Phase 1

Conditions: Systemic Mycotic Infection

Treatments: Drug: SYP-1018 200mg; Drug: Voriconazole 200mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01657201

SYP1018

Details and patient eligibility

About

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

Enrollment: 59 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Sequence 1

Experimental group

Description:

SYP-1018 200mg → Voriconazole 200mg

Treatment:

Drug: Voriconazole 200mg

Drug: SYP-1018 200mg

Sequence 2

Experimental group

Description:

Voriconazole 200mg → SYP-1018 200mg

Treatment:

Drug: Voriconazole 200mg

Drug: SYP-1018 200mg