Bioequivalence of LB80380 Free Base and Maleate Salt Tablets

LG Life Sciences

Status and phase: Completed; Phase 1

Conditions: Hepatitis B

Treatments: Drug: LB80380 maleate salt; Drug: LB80380 free base

Study type: Interventional

Funder types: Industry

Identifiers

NCT01427868

LG-BVCL009

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

32 participants in 2 patient groups

LB80380 maleat salt

Experimental group

Treatment:

Drug: LB80380 maleate salt

LB80380 free base

Active Comparator group

Treatment:

Drug: LB80380 free base