- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01427868
Bioequivalence of LB80380 Free Base and Maleate Salt Tablets
September 1, 2011 updated by: LG Life Sciences
An Open-label, Phase I Study in Healthy Male Subjects to Compare the Pharmacokinetics of LB80331 and LB80317, Metabolites of LB80380, After a Single Oral Administration of LB80380 Free Base 150 mg (60 mg + 90 mg) Tablet or LB80380 Maleate Tablet 183 mg (150 mg as a Free Base)
The study is to compare pharmacokinetics of LB80331 and LB80317, which are the metabolites of LB80380, after a single oral administration of LB80380 free base 150 mg (60 mg + 90 mg) tablet or LB80380 maleate tablet 183 mg (150 mg as a free base) in healthy male subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Clinical Trial Center, Samsung Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male with good health
- 20 to 45 years of age at screening
- Body weight ±20% of ideal body weight
- Willingness and ability to comply with study procedures and communicate with investigators
- Provided written consent voluntarily after informed of all the pertinent aspects of the trial
Exclusion Criteria:
- Clinically significant abnormality on medical interview, physical examination, electrocardiogram or clinical laboratory evaluations
- Clinically significant acute or chronic medical conditions
- Use of prescriptive medicine within 14 days, or over-the-counter drug within 7 days before the first day of drug administration
- Participation in clinical trial within 3 months before the first day of drug administration
- Alcohol abuse
- Habitual smoker
- Habitual user of herbal medicine
- Use of grapefruit-containing food or grapefruit juice during the study period
- Positive drug abuse test and Positive HBs-antigen, HCV-antibody, or HIV-antibody test
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LB80380 maleat salt
|
183 mg (150 mg as a free base)
|
Active Comparator: LB80380 free base
|
150 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUC
Time Frame: up to 144 hours
|
up to 144 hours
|
Cmax
Time Frame: up to 144 hours
|
up to 144 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Adverse Events and Number of Adverse Events as a Measure of Safety and tolerability
Time Frame: up to 7 days
|
up to 7 days
|
|
Profile of Pharmacokinetics
Time Frame: up to 144 hours
|
Tmax, Aet, CL/F
|
up to 144 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wooseong Huh, Prof, Samsung Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
August 25, 2011
First Submitted That Met QC Criteria
September 1, 2011
First Posted (Estimate)
September 2, 2011
Study Record Updates
Last Update Posted (Estimate)
September 2, 2011
Last Update Submitted That Met QC Criteria
September 1, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LG-BVCL009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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