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Pharmacokinetics Study of NI-071

NCT ID: NCT01931189

Last Updated: 2014-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-01-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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NI-071

Group Type EXPERIMENTAL

NI-071

Intervention Type BIOLOGICAL

100mg/vial

Infliximab

Group Type ACTIVE_COMPARATOR

Infliximab

Intervention Type BIOLOGICAL

100mg/vial

Interventions

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NI-071

100mg/vial

Intervention Type BIOLOGICAL

Infliximab

100mg/vial

Intervention Type BIOLOGICAL

Other Intervention Names

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Remicade

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nichi-Iko Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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NichiIko Investigational Site

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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NI071A1

Identifier Type: -

Identifier Source: org_study_id