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Comparison the Safety and Pharmacokinetic Characteristics of DWP422 25 mg With Those of ENBREL 25MG PFS INJ. After Subcutaneous Injection in Healthy Male Volunteers

NCT ID: NCT01635686

Last Updated: 2012-07-26

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-06-30

Brief Summary

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The purpose of this study was to compare the safety and pharmacokinetic characteristics of DWP422 25 mg with those of ENBREL 25MG PFS INJ. after subcutaneous injection in healthy male volunteers.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Blinding Strategy

DOUBLE

Study Groups

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DWP422

Group Type EXPERIMENTAL

DWP422 25mg

Intervention Type DRUG

ENBREL

Group Type ACTIVE_COMPARATOR

ENBREL 25MG PFS INJ.

Intervention Type DRUG

Interventions

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DWP422 25mg

Intervention Type DRUG

ENBREL 25MG PFS INJ.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy males, 20 to 45 years of age the moment of screening
2. Body mass index is between 19.0 and 27.0 kg/m2

Exclusion Criteria

1. Hypersensitivity response to the experimental and comparator drugs
2. The tuberculosis patient or latent tuberculosis patient
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Kyung-Sang Yu

Role: CONTACT

Email: [email protected]

Facility Contacts

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Kyung-Sang Yu

Role: primary

Other Identifiers

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DW_DWP422001

Identifier Type: -

Identifier Source: org_study_id