NCT01657201CompletedPhase 1
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
Samyang Biopharmaceuticals Corporation1 site in 1 country59 target enrollmentStarted: September 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics parameters
Study Overview
Brief Summary
The purpose of this study is to evaluate the pharmacokinetic properties and safety of SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Sequence 1
Experimental
SYP-1018 200mg → Voriconazole 200mg
Intervention: SYP-1018 200mg (Drug)
Sequence 1
Experimental
SYP-1018 200mg → Voriconazole 200mg
Intervention: Voriconazole 200mg (Drug)
Sequence 2
Experimental
Voriconazole 200mg → SYP-1018 200mg
Intervention: SYP-1018 200mg (Drug)
Sequence 2
Experimental
Voriconazole 200mg → SYP-1018 200mg
Intervention: Voriconazole 200mg (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics parameters
Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h
AUClast, Cmax
Secondary Outcomes
- Pharmacokinetics parameters(pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h)
- Safety(16 days)
Investigators
Study Sites (1)
Loading locations...
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