Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-01-02 @ 12:59 AM
Study NCT ID:
NCT01427868
Status:
COMPLETED
Last Update Posted:
2011-09-02
First Post:
2011-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence of LB80380 Free Base and Maleate Salt Tablets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-01', 'studyFirstSubmitDate': '2011-08-25', 'studyFirstSubmitQcDate': '2011-09-01', 'lastUpdatePostDateStruct': {'date': '2011-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC', 'timeFrame': 'up to 144 hours'}, {'measure': 'Cmax', 'timeFrame': 'up to 144 hours'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Adverse Events and Number of Adverse Events as a Measure of Safety and tolerability', 'timeFrame': 'up to 7 days'}, {'measure': 'Profile of Pharmacokinetics', 'timeFrame': 'up to 144 hours', 'description': 'Tmax, Aet, CL/F'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['LB80380', 'bioequivalence'], 'conditions': ['Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '22981147', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male with good health\n* 20 to 45 years of age at screening\n* Body weight ±20% of ideal body weight\n* Willingness and ability to comply with study procedures and communicate with investigators\n* Provided written consent voluntarily after informed of all the pertinent aspects of the trial\n\nExclusion Criteria:\n\n* Clinically significant abnormality on medical interview, physical examination, electrocardiogram or clinical laboratory evaluations\n* Clinically significant acute or chronic medical conditions\n* Use of prescriptive medicine within 14 days, or over-the-counter drug within 7 days before the first day of drug administration\n* Participation in clinical trial within 3 months before the first day of drug administration\n* Alcohol abuse\n* Habitual smoker\n* Habitual user of herbal medicine\n* Use of grapefruit-containing food or grapefruit juice during the study period\n* Positive drug abuse test and Positive HBs-antigen, HCV-antibody, or HIV-antibody test'}, 'identificationModule': {'nctId': 'NCT01427868', 'briefTitle': 'Bioequivalence of LB80380 Free Base and Maleate Salt Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Life Sciences'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'LG-BVCL009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LB80380 maleat salt', 'interventionNames': ['Drug: LB80380 maleate salt']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LB80380 free base', 'interventionNames': ['Drug: LB80380 free base']}], 'interventions': [{'name': 'LB80380 maleate salt', 'type': 'DRUG', 'description': '183 mg (150 mg as a free base)', 'armGroupLabels': ['LB80380 maleat salt']}, {'name': 'LB80380 free base', 'type': 'DRUG', 'description': '150 mg', 'armGroupLabels': ['LB80380 free base']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Clinical Trial Center, Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Wooseong Huh, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Life Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}