Phase I Trial for Pharmacokinetic Characteristics of Factive 200mg Intravenous Formulation (Gemifloxacin 200mg) With Factive 320mg Tablet Formulation (Gemifloxacin 320mg)
Primary Purpose
Infectious Diseases
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Factive® Tab / Factive IV
Sponsored by

About this trial
This is an interventional treatment trial for Infectious Diseases
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Applicants who are highly likely to take other medication during the study
- 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
- Medical history of meningitis, encephalitis, or brain injury
- Difficulty in cooperating with researchers in proceeding with the study
Sites / Locations
- Asan medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
group 1
group 2
Arm Description
received one intravenous administration and one oral medication with interval of 1 week,
received one oral administration and one intravenous medication with interval of 1 week
Outcomes
Primary Outcome Measures
AUC
Cmax
Tmax
MRT
CL
Vss
F
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01879007
Brief Title
Phase I Trial for Pharmacokinetic Characteristics of Factive 200mg Intravenous Formulation (Gemifloxacin 200mg) With Factive 320mg Tablet Formulation (Gemifloxacin 320mg)
Official Title
Phase I Trial for Pharmacokinetic Characteristics of Factive 200mg Intravenous Formulation (Gemifloxacin 200mg) With Factive 320mg Tablet Formulation (Gemifloxacin 320mg)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Life Sciences
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Experimental
Arm Description
received one intravenous administration and one oral medication with interval of 1 week,
Arm Title
group 2
Arm Type
Experimental
Arm Description
received one oral administration and one intravenous medication with interval of 1 week
Intervention Type
Drug
Intervention Name(s)
Factive® Tab / Factive IV
Primary Outcome Measure Information:
Title
AUC
Time Frame
Up to 48 hr
Title
Cmax
Time Frame
Up to 48 hr
Title
Tmax
Time Frame
Up to 48 hr
Title
MRT
Time Frame
Up to 48 hr
Title
CL
Time Frame
Up to 48 hr
Title
Vss
Time Frame
Up to 48 hr
Title
F
Time Frame
Up to 48 hr
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Applicants who are highly likely to take other medication during the study
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
Medical history of meningitis, encephalitis, or brain injury
Difficulty in cooperating with researchers in proceeding with the study
Facility Information:
Facility Name
Asan medical center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Phase I Trial for Pharmacokinetic Characteristics of Factive 200mg Intravenous Formulation (Gemifloxacin 200mg) With Factive 320mg Tablet Formulation (Gemifloxacin 320mg)
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