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OpenTrials
Completed

NCT Number: NCT01657201

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

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

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Key information

Conditions

Systemic Mycotic Infection

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research Institute, Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SYP-1018 200mg

Drug

SYP-1018 200mg, Intravenous administration

Voriconazole 200mg

Drug

Voriconazole 200mg, Intravenous administration

Primary outcomes

  1. 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

  1. Pharmacokinetics parameters

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

    AUCinf, Tmax, T1/2, CL

  2. Safety

    Time frame: 16 days

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

Sponsors and collaborators

Lead sponsor

Samyang Biopharmaceuticals Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 6, 2012
Registry last updated
Dec 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.