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

NCT01879007 | Completed Phase 1

• 1 other identifier: LG-AACL006
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infectious Diseases

Outcome Measures

Primary Outcomes (7)

• AUC

  Up to 48 hr

• Cmax

  Up to 48 hr

• Tmax

  Up to 48 hr

• MRT

  Up to 48 hr

• CL

  Up to 48 hr

• Vss

  Up to 48 hr

• F

  Up to 48 hr

Study Arms (2)

group 1

EXPERIMENTAL

received one intravenous administration and one oral medication with interval of 1 week,

Drug: Factive® Tab / Factive IV

group 2

EXPERIMENTAL

received one oral administration and one intravenous medication with interval of 1 week

Drug: Factive® Tab / Factive IV

Interventions

Factive® Tab / Factive IV DRUG

group 1; group 2

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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)
• Applicants who can take part in the whole process of clinical study
• 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

You may not qualify if:

• Applicants who exhibit symptoms suspected to be those of acute diseases prior to the start of the study
• Clinically significant kidney disease or liver disease
• 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
• Applicants who have been on an abnormal diet, which can influence the absorption, distribution, metabolism, or excretion of drugs
• Medical history of gastrointestinal resection except appendectomy
• Applicants testing positive for hepatitis B antigen, hepatitis C antibody, or HIV antibody;
• Clinically significant allergic diseases (excluding mild allergic rhinitis that does not require medication)
• Known history of hypersensitivity to drugs
• Known history of developing complications such as epilepsy or other convulsive diseases
• Excessive consumption of caffeine and alcohol or heavy smoker
• History of alcohol or drug abuse
• Applicants who cannot take the standard meals provided by ASAN Medical Center(AMC)
• Donation of whole or apheresis blood prior to the administration
• Participation in other clinical study as subjects prior to the administration
• 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

Sponsors & Collaborators

• LG Life Sciences: lead

Study Sites (1)

Asan medical center

Seoul, South Korea

Location

MeSH Terms

Conditions

Communicable Diseases

Interventions

Gemifloxacin

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 17, 2013
• Study Start: January 1, 2006
• Primary Completion: March 1, 2006
• Last Updated: June 17, 2013

Record last verified: 2013-06

Locations

KR (1)