Bioequivalence of LB80380 Free Base and Maleate Salt Tablets

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01427868
Recruitment Status : Completed
First Posted : September 2, 2011
Last Update Posted : September 2, 2011
Information provided by (Responsible Party):
LG Life Sciences

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.

Condition or disease Intervention/treatment Phase
Hepatitis B Drug: LB80380 maleate salt Drug: LB80380 free base Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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)
Study Start Date : September 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. AUC [ Time Frame: up to 144 hours ]
  2. Cmax [ Time Frame: up to 144 hours ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events and Number of Adverse Events as a Measure of Safety and tolerability [ Time Frame: up to 7 days ]
  2. Profile of Pharmacokinetics [ Time Frame: up to 144 hours ]
    Tmax, Aet, CL/F

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: September 2, 2011    Key Record Dates
Last Update Posted: September 2, 2011
Last Verified: September 2011

Keywords provided by LG Life Sciences:

Additional relevant MeSH terms:
Hepatitis B
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action