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Pharmacokinetics Study of NI-071

Sponsor
Nichi-Iko Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01931189
Collaborator
(none)
96
Enrollment
1
Location
2
Arms
5
Duration (Months)
19.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess equivalence of pharmacokinetics between NI-071 and infliximab(the comparator) in Japanese healthy volunteers

Condition or Disease Intervention/Treatment Phase
  • Biological: NI-071
  • Biological: Infliximab
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Clinical Pharmacokinetics Study of NI-071
Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Jan 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: NI-071

Biological: NI-071
100mg/vial
Active Comparator: Infliximab

Biological: Infliximab
100mg/vial
Other Names:
  • Remicade

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PK : Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt) [8 weeks]

    Secondary Outcome Measures

    1. PK : Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf) [8 weeks]

    2. Safety : Incidence of Adverse Events [8 weeks]

    3. Safety : Incidence of Anti-Drug Antibodies(ADA) [8 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Healthy male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, clinical laboratory tests, etc.)

    2. Body Mass Index (BMI) of 18.5 to 25.0 kg/m2, and a total body weight of 50 to 80 kg

    Exclusion Criteria:
    1. Subjects with a following past History or concomitant diseases

    • Chronic or recurrent infectious disease

    • Demyelinating disease

    • Congestive heart failure

    • lymphoproliferative disorder or myelodysplastic syndrome

    • Malignancy

    • Interstitial lung disease

    1. Subjects with active or latent tuberculosis or history of tuberculosis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NichiIko Investigational Site Tokyo Japan

    Sponsors and Collaborators

    • Nichi-Iko Pharmaceutical Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nichi-Iko Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01931189
    Other Study ID Numbers:
    • NI071A1
    First Posted:
    Aug 29, 2013
    Last Update Posted:
    Jun 30, 2014
    Last Verified:
    Jun 1, 2014
    Additional relevant MeSH terms:
    Infliximab

    Study Results

    No Results Posted as of Jun 30, 2014