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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
Phase 1 trial testing SK Antithrombin III in Healthy in 20 participants. Completed in 1 December 2008.
1 December 2008
Quick facts
| Lead sponsor | SK Chemicals Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 October 2008 |
| Primary completion | 1 December 2008 |
| Estimated completion | 1 December 2008 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- SK Antithrombin III — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
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.
-
ATIII activity
Time frame: within 20min after injection ATIII
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):
-
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:
- PubMed search for NCT00846274
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other SK Chemicals Co., Ltd. trials
Trials by the same sponsor.
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- NCT05453786 — A Pharmacokinetic Study of SID1903 (FDC of Dapagliflozin and Sitagliptin) in Healthy Adult Volunteers · Phase 1 · completed
- NCT05236998 — A Pharmacokinetic Study of SID1903 (FDC of Dapagliflozin and Sitagliptin) in Healthy Adult Volunteers · Phase 1 · completed
- NCT05906199 — A Study to Compare the Effects of Improving the Carotid Artery Intima Media Thickness and Changing Lipid Levels by Cilos · Phase 4 · completed
- NCT04821687 — A Study to Evaluate the add-on Efficacy and Safety of Opicapone 50 mg or an Extra Dose of L-DOPA 100 mg for the Treatmen · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00846274 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by SK Chemicals Co., Ltd.
- Last refreshed: 17 February 2009
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing