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NCT00846274

Single-Dose, Open Label, Randomized Comparative Clinical Trial to Evaluate the Tolerability, Safety and PK/PD of Human ATIII Products, "SKATIII Injection" and"ATIII Injection" in Healthy Male Subjects

Completed Phase 1 Last updated 17 February 2009
What this trial tests

Phase 1 trial testing SK Antithrombin III in Healthy in 20 participants. Completed in 1 December 2008.

Timeline
1 October 2008
Primary endpoint
1 December 2008
1 December 2008

Quick facts

Lead sponsorSK Chemicals Co., Ltd.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposetreatment
Enrollment20
Start date1 October 2008
Primary completion1 December 2008
Estimated completion1 December 2008
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

SK Chemicals Co., Ltd. — full company profile →

Who can join

Adults 19 to 40, male only, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Bioequivalence of two intravenous formulations of antithrombin III: a two-way crossover study in healthy Korean subjects.
    Kim KA, Lim YY, Kim SH, Park JY. · · 2013 · cited 1× · PMID 24094463 · DOI 10.1016/j.clinthera.2013.08.018

Verify or expand the search:

Other recruiting trials for Healthy

Currently open trials in the same condition.

Other SK Chemicals Co., Ltd. trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00846274.

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