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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2006

Interventions

  • Drug: Factive┬« Tab / Factive IV

Arms, Groups and Cohorts

  • Experimental: group 1
    • received one intravenous administration and one oral medication with interval of 1 week,
  • Experimental: group 2
    • received one oral administration and one intravenous medication with interval of 1 week

Clinical Trial Outcome Measures

Primary Measures

  • AUC
    • Time Frame: Up to 48 hr
  • Cmax
    • Time Frame: Up to 48 hr
  • Tmax
    • Time Frame: Up to 48 hr
  • MRT
    • Time Frame: Up to 48 hr
  • CL
    • Time Frame: Up to 48 hr
  • Vss
    • Time Frame: Up to 48 hr
  • F
    • Time Frame: Up to 48 hr

Participating in This Clinical Trial

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 11. History of alcohol or drug abuse 12. Applicants who cannot take the standard meals provided by ASAN Medical Center(AMC) 13. Donation of whole or apheresis blood prior to the administration 14. Participation in other clinical study as subjects prior to the administration 15. Applicants who have taken prescription drugs prior to the administration or OTC(over-the-counter) drugs prior to the administration and for which such medications are judged by the principal investigator to have an influence on this study or on the safety of the subject 16. Applicants who are highly likely to take other medication during the study 17. Applicants who took medication that induces or inhibits drug-metabolizing enzymes such as barbiturates or consumed excessive amounts of alcohol less than 1 month prior to the administration 18. Medical history of meningitis, encephalitis, or brain injury 19. Difficulty in cooperating with researchers in proceeding with the study

Gender Eligibility: Male

Minimum Age: 19 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • LG Life Sciences
  • Provider of Information About this Clinical Study
    • Sponsor

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