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

Phase 1 Completed 20 enrolled SK Chemicals Co., Ltd. Korea University Anam Hospital · collab

RandomizedCrossoverOpen-labelTreatment

Summary

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

Timeline

Start: 2008-10
Primary completion: 2008-12
Completion: 2008-12

Outcome

Met primary endpoint

paper The results of the present study showed that these 2 AT-III formulations met the regulatory criteria for pharmacokinetic bioequivalence PMID 24094463 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SK Antithrombin III	Unknown	100 iu/kg	Intravenous

Indications

No indication recorded.