Bioequivalence of LB80380 Free Base and Maleate Salt Tablets

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: LG Life Sciences
• Treatments: Maleic acid

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