Bioequivalence of LB80380 Free Base and Maleate Salt Tablets

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01427868
First received: August 25, 2011
Last updated: September 1, 2011
Last verified: September 2011

August 25, 2011
September 1, 2011
September 2010
November 2010   (final data collection date for primary outcome measure)
  • AUC [ Time Frame: up to 144 hours ] [ Designated as safety issue: No ]
  • Cmax [ Time Frame: up to 144 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01427868 on ClinicalTrials.gov Archive Site
  • Number of Participants with Adverse Events and Number of Adverse Events as a Measure of Safety and tolerability [ Time Frame: up to 7 days ] [ Designated as safety issue: Yes ]
  • Profile of Pharmacokinetics [ Time Frame: up to 144 hours ] [ Designated as safety issue: No ]
    Tmax, Aet, CL/F
Same as current
Not Provided
Not Provided
 
Bioequivalence of LB80380 Free Base and Maleate Salt Tablets
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)

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Hepatitis B
  • Drug: LB80380 maleate salt
    183 mg (150 mg as a free base)
  • Drug: LB80380 free base
    150 mg
  • Experimental: LB80380 maleat salt
    Intervention: Drug: LB80380 maleate salt
  • Active Comparator: LB80380 free base
    Intervention: Drug: LB80380 free base
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
December 2010
November 2010   (final data collection date for primary outcome measure)

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
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01427868
LG-BVCL009
No
LG Life Sciences
LG Life Sciences
Not Provided
Principal Investigator: Wooseong Huh, Prof Samsung Medical Center
LG Life Sciences
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP