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OpenTrials
Completed

NCT Number: NCT01427868

Bioequivalence of LB80380 Free Base and Maleate Salt Tablets

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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Center, Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LB80380 maleate salt

Drug

183 mg (150 mg as a free base)

LB80380 free base

Drug

150 mg

Primary outcomes

  1. AUC

    Time frame: up to 144 hours

  2. Cmax

    Time frame: up to 144 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 2, 2011
Registry last updated
Sep 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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