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Bioequivalence of LB80380 Free Base and Maleate Salt Tablets

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01427868
First received: August 25, 2011
Last updated: September 1, 2011
Last verified: September 2011
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427868

Locations
Korea, Republic of
Clinical Trial Center, Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: LG Life Sciences
ClinicalTrials.gov 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:
LB80380
bioequivalence

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

ClinicalTrials.gov processed this record on May 19, 2013