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Bioequivalence of LB80380 Free Base and Maleate Salt Tablets

This study has been completed.
Information provided by (Responsible Party):
LG Life Sciences Identifier:
First received: August 25, 2011
Last updated: September 1, 2011
Last verified: September 2011

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.

Condition Intervention Phase
Hepatitis B
Drug: LB80380 maleate salt
Drug: LB80380 free base
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • AUC [ Time Frame: up to 144 hours ] [ Designated as safety issue: No ]
  • Cmax [ Time Frame: up to 144 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events and Number of Adverse Events as a Measure of Safety and tolerability [ Time Frame: up to 7 days ] [ Designated as safety issue: Yes ]
  • Profile of Pharmacokinetics [ Time Frame: up to 144 hours ] [ Designated as safety issue: No ]
    Tmax, Aet, CL/F

Enrollment: 32
Study Start Date: September 2010
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LB80380 maleat salt Drug: LB80380 maleate salt
183 mg (150 mg as a free base)
Active Comparator: LB80380 free base Drug: LB80380 free base
150 mg


Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01427868

Korea, Republic of
Clinical Trial Center, Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
Principal Investigator: Wooseong Huh, Prof Samsung Medical Center
  More Information

No publications provided by LG Life Sciences

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: LG Life Sciences Identifier: NCT01427868     History of Changes
Other Study ID Numbers: LG-BVCL009
Study First Received: August 25, 2011
Last Updated: September 1, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by LG Life Sciences:
bioequivalence processed this record on March 03, 2015