Bioequivalence of LB80380 Free Base and Maleate Salt Tablets

NCT ID: NCT01427868

Last Updated: 2011-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2010-12-31

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.

Conditions

Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

LB80380 maleat salt

Group Type: EXPERIMENTAL

LB80380 maleate salt

Intervention Type: DRUG

183 mg (150 mg as a free base)

LB80380 free base

Group Type: ACTIVE_COMPARATOR

LB80380 free base

Intervention Type: DRUG

150 mg

Interventions

LB80380 maleate salt

183 mg (150 mg as a free base)

Intervention Type: DRUG

LB80380 free base

150 mg

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

LG Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wooseong Huh, Prof

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Clinical Trial Center, Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

References

Jung JA, Kim SR, Kim TE, Kim JR, Lee SY, Huh W, Ko JW. Pharmacokinetic comparison of the maleate and free base formulations of LB80380, a novel nucleotide analog, in healthy male volunteers. Int J Clin Pharmacol Ther. 2012 Sep;50(9):657-64. doi: 10.5414/cp201716.

Reference Type: DERIVED

PMID: 22981147 (View on PubMed)

Other Identifiers

LG-BVCL009

Identifier Type: -

Identifier Source: org_study_id