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

NCT ID: NCT01879007

Last Updated: 2013-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group 1

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

Group Type: EXPERIMENTAL

Factive® Tab / Factive IV

Intervention Type: DRUG

group 2

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

Group Type: EXPERIMENTAL

Factive® Tab / Factive IV

Intervention Type: DRUG

Interventions

Factive® Tab / Factive IV

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

LG Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asan medical center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

LG-AACL006

Identifier Type: -

Identifier Source: org_study_id