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

Primary Purpose

Systemic Mycotic Infection

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

SYP-1018 200mg

Voriconazole 200mg

About this trial

This is an interventional treatment trial for Systemic Mycotic Infection

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts 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)

Sites / Locations

Clinical Research Institute, Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Sequence 1

Sequence 2

Arm Description

SYP-1018 200mg → Voriconazole 200mg

Voriconazole 200mg → SYP-1018 200mg

Outcomes

Primary Outcome Measures

Pharmacokinetics parameters

AUClast, Cmax

Secondary Outcome Measures

Pharmacokinetics parameters

AUCinf, Tmax, T1/2, CL

Safety

Adverse events, Laboratory assessments, Vital signs, Electrocardiograms(ECGs)

Full Information

NCT ID

NCT01657201

First Posted

July 29, 2012

Last Updated

December 20, 2012

Sponsor

Samyang Biopharmaceuticals Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01657201

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Samyang Biopharmaceuticals Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Mycotic Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sequence 1

Arm Type

Experimental

Arm Description

SYP-1018 200mg → Voriconazole 200mg

Arm Title

Sequence 2

Arm Type

Experimental

Arm Description

Voriconazole 200mg → SYP-1018 200mg

Intervention Type

Drug

Intervention Name(s)

SYP-1018 200mg

Intervention Description

SYP-1018 200mg, Intravenous administration

Intervention Type

Drug

Intervention Name(s)

Voriconazole 200mg

Intervention Description

Voriconazole 200mg, Intravenous administration

Primary Outcome Measure Information:

Title

Pharmacokinetics parameters

Description

AUClast, Cmax

Time Frame

pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h

Secondary Outcome Measure Information:

Title

Pharmacokinetics parameters

Description

AUCinf, Tmax, T1/2, CL

Time Frame

pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h

Title

Safety

Description

Adverse events, Laboratory assessments, Vital signs, Electrocardiograms(ECGs)

Time Frame

16 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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)

Facility Information:

Facility Name

Clinical Research Institute, Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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