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

Infectious Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01879007
• Other study ID #: LG-AACL006
• Status: Completed
• Phase: Phase 1
• First received: June 4, 2013
• Last updated: June 13, 2013
• Start date: January 2006

Study information

• Verified date: June 2013
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. primary completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Diseases

Intervention

Drug:
• Factive® Tab / Factive IV

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC		Up to 48 hr	No
Primary	Cmax		Up to 48 hr	No
Primary	Tmax		Up to 48 hr	No
Primary	MRT		Up to 48 hr	No
Primary	CL		Up to 48 hr	No
Primary	Vss		Up to 48 hr	No
Primary	F		Up to 48 hr	No