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A Clinical Trial to Evaluate the Pharmacokinetics and Safety of NVP-1402 in Healthy Male Subjects (NCT02897726)

The purpose of this study is to evaluate and compare the safety and pharmacokinetics of NVP-1402 and NVP-1402R in healthy male subjects.
  • Drug: NVP-1402
    Oral
    • Drug: NVP-1402R
      Oral
      • Active comparator
    Ages eligible for Study
    19 Years and older
    Genders eligible for Study
    Male
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Inclusion Criteria:
    • Healthy males
    • No history of clinically significant medical disorder
    • Capable of consent to participate in the study
    Exclusion Criteria:
    • History of hypersensitive reactions to study drug or other related drugs
    • Any significant abnormality found during screening
    • Any significant medical history
    • History of alcohol abuse, smoking continuously
    • History of drug abuse
    • Clinically significant surgery within 4 weeks prior to administration of the study drug
    • Participation in another clinical trial within 3 months prior to administration of the study drug
    This study is designed as randomized, open-label, active-controlled and crossover assignment for evaluate and compare the safety and pharmacokinetics of NVP-1402 and NVP-1402R in healthy male subjects. The safety assessed through adverse events up to 17 days after administration. Additional variables (ECGs, laboratory test, vital signs, so on) will also be recorded and assessed.

    1 locations

    Korea, Republic of (1)
    • Navipharm
      Not specified
      Suwon-si, Gyeonggi-do, Korea, Republic of, 16209
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    23 March, 2017
    Updated:
    05 August, 2017
    Participants:
    38
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