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

Systemic Mycotic Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657201
• Other study ID #: SYP1018
• Status: Completed
• Phase: Phase 1
• First received: July 29, 2012
• Last updated: December 20, 2012
• Start date: September 2012
• Est. completion date: November 2012

Study information

• Verified date: December 2012
• Source: Samyang Biopharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mycoses
• Systemic Mycotic Infection

Intervention

Drug:
• SYP-1018 200mg
SYP-1018 200mg, Intravenous administration
• Voriconazole 200mg
Voriconazole 200mg, Intravenous administration

Locations

Country	Name	City	State
Korea, Republic of	Clinical Research Institute, Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samyang Biopharmaceuticals Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics parameters	AUClast, Cmax	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h	No
Secondary	Pharmacokinetics parameters	AUCinf, Tmax, T1/2, CL	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h	No
Secondary	Safety	Adverse events, Laboratory assessments, Vital signs, Electrocardiograms(ECGs)	16 days	Yes