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

NCT ID: NCT01657201

Last Updated: 2012-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-11-30

Brief Summary

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

Detailed Description

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Conditions

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Systemic Mycotic Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1

SYP-1018 200mg → Voriconazole 200mg

Group Type EXPERIMENTAL

SYP-1018 200mg

Intervention Type DRUG

SYP-1018 200mg, Intravenous administration

Voriconazole 200mg

Intervention Type DRUG

Voriconazole 200mg, Intravenous administration

Sequence 2

Voriconazole 200mg → SYP-1018 200mg

Group Type EXPERIMENTAL

SYP-1018 200mg

Intervention Type DRUG

SYP-1018 200mg, Intravenous administration

Voriconazole 200mg

Intervention Type DRUG

Voriconazole 200mg, Intravenous administration

Interventions

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SYP-1018 200mg

SYP-1018 200mg, Intravenous administration

Intervention Type DRUG

Voriconazole 200mg

Voriconazole 200mg, Intravenous administration

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Samyang Biopharmaceuticals Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Research Institute, Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SYP1018

Identifier Type: -

Identifier Source: org_study_id