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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01657201

Enrollment

Registered

2012-08-06

Start date

2012-09-30

Completion date

2012-11-30

Last updated

2012-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Mycotic Infection

Brief summary

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

Interventions

DRUGSYP-1018 200mg

SYP-1018 200mg, Intravenous administration

DRUGVoriconazole 200mg

Voriconazole 200mg, Intravenous administration

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics parameters	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h	AUClast, Cmax

Secondary

Measure	Time frame	Description
Pharmacokinetics parameters	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h	AUCinf, Tmax, T1/2, CL
Safety	16 days	Adverse events, Laboratory assessments, Vital signs, Electrocardiograms(ECGs)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026