Infectious DiseasesPhase 1NCT01879007
Phase I Trial for Pharmacokinetic Characteristics of Factive 200mg Intravenous Formulation (Gemifloxacin 200mg) With Factive 320mg Tablet Formulation (Gemifloxacin 320mg)
A Phase 1 study testing Factive® Tab / Factive IV in people with Infectious Diseases, run by LG Life Sciences at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infectious Diseases
- What is being tested?
- Factive® Tab / Factive IV
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2006to Mar 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Factive® Tab / Factive IV
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Factive® Tab / Factive IVDrug
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | received one intravenous administration and one oral medication with interval of 1 week, Receives: Drug: Factive® Tab / Factive IV |
| group 2 | Experimental | received one oral administration and one intravenous medication with interval of 1 week Receives: Drug: Factive® Tab / Factive IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Measured: Up to 48 hr
Cmax
Measured: Up to 48 hr
Tmax
Measured: Up to 48 hr
MRT
Measured: Up to 48 hr
CL
Measured: Up to 48 hr
Vss
Measured: Up to 48 hr
F
Measured: Up to 48 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startJan 2006
- Primary completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879007
- Sponsor's protocol ID
- LG-AACL006
- Status last verified
- Jun 2013
- First submitted
- 4 Jun 2013
- Last updated
- 17 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial for Pharmacokinetic Characteristics of Factive 200mg Intravenous Formulation (Gemifloxacin 200mg) With Factive 320mg Tablet Formulation (Gemifloxacin 320mg)
- ClinicalTrials.gov ID
- NCT01879007
- Acronym / sponsor ID
- LG-AACL006
- Conditions
- Infectious Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Mar 2006 (actual)
- First posted
- 17 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: Factive® Tab / Factive IVreceived one intravenous administration and one oral medication with interval of 1 week, |
| group 2 | Experimental | Drug: Factive® Tab / Factive IVreceived one oral administration and one intravenous medication with interval of 1 week |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Factive® Tab / Factive IV | Drug | group 1, group 2 |
Primary outcome
AUC
Time frame: Up to 48 hr
Cmax
Time frame: Up to 48 hr
Tmax
Time frame: Up to 48 hr
MRT
Time frame: Up to 48 hr
CL
Time frame: Up to 48 hr
Vss
Time frame: Up to 48 hr
F
Time frame: Up to 48 hr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Factive® Tab / Factive IV in people with Infectious Diseases, run by LG Life Sciences at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (time frame: Up to 48 hr). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2013.