Phase1 Syudy to Evaluate the Safety and PK/PD of Human Antithrombin III

NCT ID: NCT00846274

Last Updated: 2009-02-18

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2008-12-31

Brief Summary

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To evaluate the PK/PD of single injected human ATIII Products, SKATIII and ATIII, phase1 study in healthy male subjects was designed

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antithrombin III

Group Type ACTIVE_COMPARATOR

SK Antithrombin III

Intervention Type BIOLOGICAL

SK Antithrombin III

Group Type EXPERIMENTAL

SK Antithrombin III

Intervention Type BIOLOGICAL

Interventions

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SK Antithrombin III

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* ages 19 to 40
* Body weight: More than 50kg
* Healthy male subject

Exclusion Criteria

* Hb\<14g/dL, Hct\<42%
* ATIII hypersensitivity
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Korea University Anam Hospital

OTHER

Sponsor Role collaborator

SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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SK Chemicals Co.,Ltd.

Principal Investigators

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Ji Young Park, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

Locations

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SK chemicals

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim KA, Lim YY, Kim SH, Park JY. Bioequivalence of two intravenous formulations of antithrombin III: a two-way crossover study in healthy Korean subjects. Clin Ther. 2013 Nov;35(11):1752-61. doi: 10.1016/j.clinthera.2013.08.018. Epub 2013 Oct 1.

Reference Type DERIVED
PMID: 24094463 (View on PubMed)

Other Identifiers

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SKATIII_I_2007

Identifier Type: -

Identifier Source: org_study_id

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