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

• ClinicalTrials.gov Identifier: NCT01879007
• Recruitment Status: Completed
• First Posted: June 17, 2013
• Last Update Posted: June 17, 2013
• Sponsor: LG Life Sciences
• Information provided by (Responsible Party): LG Life Sciences

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.

Condition or disease	Intervention/treatment	Phase
Infectious Diseases	Drug: Factive® Tab / Factive IV	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I Trial for Pharmacokinetic Characteristics of Factive 200mg Intravenous Formulation (Gemifloxacin 200mg) With Factive 320mg Tablet Formulation (Gemifloxacin 320mg)
• Study Start Date: January 2006
• Actual Primary Completion Date: March 2006

Arms and Interventions

Arm	Intervention/treatment
Experimental: group 1; received one intravenous administration and one oral medication with interval of 1 week,	Drug: Factive® Tab / Factive IV
Experimental: group 2; received one oral administration and one intravenous medication with interval of 1 week	Drug: Factive® Tab / Factive IV

Outcome Measures

Primary Outcome Measures :

1. AUC [ Time Frame: Up to 48 hr ]
2. Cmax [ Time Frame: Up to 48 hr ]
3. Tmax [ Time Frame: Up to 48 hr ]
4. MRT [ Time Frame: Up to 48 hr ]
5. CL [ Time Frame: Up to 48 hr ]
6. Vss [ Time Frame: Up to 48 hr ]
7. F [ Time Frame: Up to 48 hr ]

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 45 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Korea, Republic of

Asan medical center

Seoul, Korea, Republic of

Sponsors and Collaborators

LG Life Sciences

More Information

• Responsible Party: LG Life Sciences
• ClinicalTrials.gov Identifier: NCT01879007
• Other Study ID Numbers: LG-AACL006
• First Posted: June 17, 2013
• Last Update Posted: June 17, 2013
• Last Verified: June 2013

Additional relevant MeSH terms:

Communicable Diseases; Infections; Disease Attributes; Pathologic Processes; Gemifloxacin; Anti-Bacterial Agents; Anti-Infective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents