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Phase I Trial for Pharmacokinetic Characteristics of Factive 200mg Intravenous Formulation (Gemifloxacin 200mg) With Factive 320mg Tablet Formulation (Gemifloxacin 320mg) | Clinical Trials | Clareo Health

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Phase I Trial for Pharmacokinetic Characteristics of Factive 200mg Intravenous Formulation (Gemifloxacin 200mg) With Factive 320mg Tablet Formulation (Gemifloxacin 320mg)

NCT01879007•LG Life Sciences

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

19 - 45 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy Korean males between 19 and 45 years of age, weighing within 15% deviation of the ideal weight (CRC criteria) and residing in Korea (Appendix 4)
•2. Applicants judged eligible as subject based on health exams (interview, blood pressure, 12-lead ECG, physical exam, blood and urine tests, and other screening tests) conducted not more than three weeks prior to administration (those with two or less clinically significant results)
•3. Applicants who can take part in the whole process of clinical study
•4. Applicants who sufficiently received explanation on the purpose and content of clinical study, characteristics of the investigational products, etc., before participating in the study and gave written consent to participate in the study voluntarily

Exclusion Criteria

•1. Applicants who exhibit symptoms suspected to be those of acute diseases prior to the start of the study
•2. Clinically significant kidney disease or liver disease
•3. Cardiovascular, respiratory, renal, endocrine system, hematology (hemorrhagic diathresis), digestive system (peptic ulcer), central nerve system, psychiatric disorder, or malignant tumors; chronic diseases that can influence the absorption, distribution, metabolism, or excretion of drugs
•4. Applicants who have been on an abnormal diet, which can influence the absorption, distribution, metabolism, or excretion of drugs
•5. Medical history of gastrointestinal resection except appendectomy
•6. Applicants testing positive for hepatitis B antigen, hepatitis C antibody, or HIV antibody;
•7. Clinically significant allergic diseases (excluding mild allergic rhinitis that does not require medication)
•8. Known history of hypersensitivity to drugs
•9. Known history of developing complications such as epilepsy or other convulsive diseases
•10. Excessive consumption of caffeine and alcohol or heavy smoker
+9 more criteria

Locations (1)

Asan medical center

Seoul, South Korea

Key Dates

Start Date

January 1, 2006

Primary Completion Date

March 1, 2006

Last Updated

June 17, 2013

Enrollment

ACTUAL participants

Conditions

Infectious Diseases

Interventions

Factive® Tab / Factive IV

DRUG

Prescription Support System for Antimicrobial Use in Belgian Primary Care

NCT07347015

Infectious Diseases

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RECRUITING

Establishment of a Biobank for the Evaluation of Rapid Diagnostic Solutions

NCT07411729

Emerging Infectious DiseasesCommunicable Diseases+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 17, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase I Trial for Pharmacokinetic Characteristics of Factive 200mg Intravenous Formulation (Gemifloxacin 200mg) With Factive 320mg Tablet Formulation (Gemifloxacin 320mg)

Inclusion Criteria

Exclusion Criteria

Prescription Support System for Antimicrobial Use in Belgian Primary Care

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