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Last Updated: April 17, 2021

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CLINICAL TRIALS PROFILE FOR FACTIVE

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All Clinical Trials for FACTIVE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01879007 Phase I Trial for Pharmacokinetic Characteristics of Factive 200mg Intravenous Formulation (Gemifloxacin 200mg) With Factive 320mg Tablet Formulation (Gemifloxacin 320mg) Completed LG Life Sciences Phase 1 2006-01-01 This study seeks to compare the pharmacokinetic characteristics of Factive 200mg Intravenous Formulation (Gemifloxacin 200mg) with those of Factive 320mg Tablet Formulation (Gemifloxacin 320mg) and to explore possibility of clinical use of the IV formulation.
NCT02368470 Randomized Study on Efficacy of Gemifloxacin-based Regimen for Helicobacter Pylori Infection Recruiting Samsung Medical Center Phase 3 2015-02-01 New generations of fluoroquinolones, like levofloxacin and moxifloxacin, exhibit a broad-spectrum activity against Gram-positive and Gram-negative bacteria, and have been successfully introduced into the treatment of Helicobacter pylori infection. However, it was suggested that resistance to fluoroquinolones has been increasing in the Korean population and the resistance is most likely mediated through point mutation in gyrA. Gemifloxacin (FACTIVE®) is an enhanced-affinity, broad-spectrum fluoroquinolone suitable for once-daily, oral dosing. In vitro studies have shown that gemifloxacin displays potent activity against Gram-positive organisms, whilst retaining good activity against Gram-negative organisms. Gemifloxacin is the most potent member of the quinolone class against S. pneumoniae with activities 16-64 times greater than those of ciprofloxacin and ofloxacin and 2-8 times greater than those of moxifloxacin. Importantly, gemifloxacin displays potent in vitro activity against strains of S. pneumoniae with known resistance to β-lactams, macrolides and other members of the quinolone class. This potent activity is believed to be due to the enhanced affinity of gemifloxacin for topoisomerase IV, the major fluoroquinolone target in S. pneumoniae. Furthermore, gemifloxacin displays potent activity against H. influenzae and M. catarrhalis and atypical organisms such as L. pneumophila, C. pneumoniae and M. pneumoniae. It has proven particularly effective in respiratory and urinary tract infection.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for FACTIVE

Condition Name

Condition Name for FACTIVE
Intervention Trials
Infectious Diseases 1
Helicobacter Pylori Infection 1
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Condition MeSH

Condition MeSH for FACTIVE
Intervention Trials
Infection 2
Communicable Diseases 2
Helicobacter Infections 1
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Clinical Trial Locations for FACTIVE

Trials by Country

Trials by Country for FACTIVE
Location Trials
Korea, Republic of 2
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Clinical Trial Progress for FACTIVE

Clinical Trial Phase

Clinical Trial Phase for FACTIVE
Clinical Trial Phase Trials
Phase 3 1
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for FACTIVE
Clinical Trial Phase Trials
Completed 1
Recruiting 1
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Clinical Trial Sponsors for FACTIVE

Sponsor Name

Sponsor Name for FACTIVE
Sponsor Trials
Samsung Medical Center 1
LG Life Sciences 1
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Sponsor Type

Sponsor Type for FACTIVE
Sponsor Trials
Other 1
Industry 1
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Johnson and Johnson
McKinsey
Moodys
Medtronic

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