Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT01657201
First received: July 29, 2012
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Systemic Mycotic Infection
 Drug: SYP-1018 200mg
Drug: Voriconazole 200mg
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samyang Biopharmaceuticals Corporation:

Primary Outcome Measures:
  • Pharmacokinetics parameters [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h ] [ Designated as safety issue: No ]
    AUClast, Cmax


Secondary Outcome Measures:
  • Pharmacokinetics parameters [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h ] [ Designated as safety issue: No ]
    AUCinf, Tmax, T1/2, CL

  • Safety [ Time Frame: 16 days ] [ Designated as safety issue: Yes ]
    Adverse events, Laboratory assessments, Vital signs, Electrocardiograms(ECGs)


Enrollment: 59
Study Start Date: September 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1
SYP-1018 200mg → Voriconazole 200mg
 Drug: SYP-1018 200mg
SYP-1018 200mg, Intravenous administration
Drug: Voriconazole 200mg
Voriconazole 200mg, Intravenous administration
Experimental: Sequence 2
Voriconazole 200mg → SYP-1018 200mg
 Drug: SYP-1018 200mg
SYP-1018 200mg, Intravenous administration
Drug: Voriconazole 200mg
Voriconazole 200mg, Intravenous administration

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657201

Locations
Korea, Republic of
Clinical Research Institute, Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Samyang Biopharmaceuticals Corporation
  More Information

No publications provided

Responsible Party: Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01657201     History of Changes
Other Study ID Numbers: SYP1018
Study First Received: July 29, 2012
Last Updated: December 20, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Mycoses
Voriconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013