Bioequivalence of LB80380 Free Base and Maleate Salt Tablets
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)
1 other identifier
interventional
32
1 country
1
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 maleate tablet 183 mg (150 mg as a free base) in healthy male subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 25, 2011
CompletedFirst Posted
Study publicly available on registry
September 2, 2011
CompletedSeptember 2, 2011
September 1, 2011
2 months
August 25, 2011
September 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
AUC
up to 144 hours
Cmax
up to 144 hours
Secondary Outcomes (2)
Number of Participants with Adverse Events and Number of Adverse Events as a Measure of Safety and tolerability
up to 7 days
Profile of Pharmacokinetics
up to 144 hours
Study Arms (2)
LB80380 maleat salt
EXPERIMENTALLB80380 free base
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male with good health
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LG Life Scienceslead
Study Sites (1)
Clinical Trial Center, Samsung Medical Center
Seoul, South Korea
Related Publications (1)
Jung JA, Kim SR, Kim TE, Kim JR, Lee SY, Huh W, Ko JW. Pharmacokinetic comparison of the maleate and free base formulations of LB80380, a novel nucleotide analog, in healthy male volunteers. Int J Clin Pharmacol Ther. 2012 Sep;50(9):657-64. doi: 10.5414/cp201716.
PMID: 22981147DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wooseong Huh, Prof
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2011
First Posted
September 2, 2011
Study Start
September 1, 2010
Primary Completion
November 1, 2010
Study Completion
December 1, 2010
Last Updated
September 2, 2011
Record last verified: 2011-09