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Pharmacokinetics Study of NI-071

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01931189
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : June 30, 2014
Information provided by (Responsible Party):
Nichi-Iko Pharmaceutical Co., Ltd.

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
Healthy Biological: NI-071 Biological: Infliximab Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : August 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arm Intervention/treatment
Experimental: NI-071 Biological: NI-071

Active Comparator: Infliximab Biological: Infliximab
Other Name: Remicade

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

Secondary Outcome Measures :
  1. PK : Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf) [ Time Frame: 8 weeks ]
  2. Safety : Incidence of Adverse Events [ Time Frame: 8 weeks ]
  3. Safety : Incidence of Anti-Drug Antibodies(ADA) [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
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
  2. Subjects with active or latent tuberculosis or history of tuberculosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01931189

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NichiIko Investigational Site
Tokyo, Japan
Sponsors and Collaborators
Nichi-Iko Pharmaceutical Co., Ltd.
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Responsible Party: Nichi-Iko Pharmaceutical Co., Ltd. Identifier: NCT01931189    
Other Study ID Numbers: NI071A1
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: June 30, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents