Bioequivalence of LB80380 Free Base and Maleate Salt Tablets

Hepatitis B Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427868
• Other study ID #: LG-BVCL009
• Status: Completed
• Phase: Phase 1
• First received: August 25, 2011
• Last updated: September 1, 2011
• Start date: September 2010
• Est. completion date: December 2010

Study information

• Verified date: September 2011
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatitis B

Intervention

Drug:
• LB80380 maleate salt
183 mg (150 mg as a free base)
• LB80380 free base
150 mg

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center, Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC		up to 144 hours	No
Primary	Cmax		up to 144 hours	No
Secondary	Number of Participants with Adverse Events and Number of Adverse Events as a Measure of Safety and tolerability		up to 7 days	Yes
Secondary	Profile of Pharmacokinetics	Tmax, Aet, CL/F	up to 144 hours	No