Status:
COMPLETED
Bioequivalence of LB80380 Free Base and Maleate Salt Tablets
Lead Sponsor:
LG Life Sciences
Conditions:
Hepatitis B
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01427868
Start Date
September 1 2010
End Date
December 1 2010
Last Update
September 2 2011
Active Locations (1)
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1
Clinical Trial Center, Samsung Medical Center
Seoul, South Korea