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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014