Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-07 @ 8:47 PM
Study NCT ID:
NCT01635751
Status:
COMPLETED
Last Update Posted:
2013-01-28
First Post:
2012-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS Tablet 150mg With Immediate Release Formulation and to Assess The Effect of High Fat Diet in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-25', 'studyFirstSubmitDate': '2012-07-04', 'studyFirstSubmitQcDate': '2012-07-09', 'lastUpdatePostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': '36hrs', 'description': 'Pharmacokinetic of Pregabalin'}, {'measure': 'Tmax', 'timeFrame': '36hrs', 'description': 'Pharmacokinetic of Pregabalin'}, {'measure': 'AUC0-36h', 'timeFrame': '36hrs', 'description': 'Pharmacokinetic of Pregabalin'}, {'measure': 'AUC0-∞', 'timeFrame': '36hrs', 'description': 'Pharmacokinetic of Pregabalin'}, {'measure': 'CL/F', 'timeFrame': '36hrs', 'description': 'Pharmacokinetic of Pregabalin'}, {'measure': 'Vd/F', 'timeFrame': '36hrs', 'description': 'Pharmacokinetic of Pregabalin'}, {'measure': 'T1/2', 'timeFrame': '36hrs', 'description': 'Pharmacokinetic of Pregabalin'}], 'secondaryOutcomes': [{'measure': 'Safety Monitoring', 'timeFrame': '23 days', 'description': 'Adverse Event, Vital sign, 12-lead ECG, Laboratory test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pregabalin', 'GLARS'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg.\n\nGLA5PR GLARS tablet 150mg is a new once-a-day formulation which is made by GL Pharm Tech corporation.\n\nGLARS(Geometrically Long Absorption Regulated System) is new solution to sustained absorption by extending the absorption Site.\n\nTo overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".', 'detailedDescription': 'Basically, this system is a triple-layered tablet, comprised of upper and lower layers that swell and draw a sufficient amount of water, plus a highly water - soluble middle layer that rapidly draw water into the tablet core simultaneously.\n\nThe water drawn into the tablet (about 3 to 4 times the weight of the tablet itself) functions as an additional media which enables additional and later drug release out of the dosage form. This serves to overcome the shortage of surrounding media that has been reported to be one of the key reasons for malabsorption of a drug in colon.\n\nAs the middle layer induces a rapid water draw into the tablet core, the penetrated water also diffuses to the upper and lower layers, which makes the tablet to rapidly swell and controls drug release.\n\nAt virtually the same time, the swollen upper and lower layers form to surround a lateral side of the middle layer, which can, in turn, further control drug release.\n\nThis relatively rigid swollen matrix structure makes drug release not affected by surrounding mechanical flux, which can provide relatively consistent in vivo drug release irrespective of degree of gastrointestinal motility.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20\\~45 years old, Healthy Adult Male Subject\n* ≥ 50kg(Body Weight) and Ideal Body Weight ≤ ±20%\n\nExclusion Criteria:\n\n* ALT or AST \\> 1.25(Upper Normal Range)\n* Total Bilirubin \\> 1.5 (Upper Normal Range)'}, 'identificationModule': {'nctId': 'NCT01635751', 'acronym': 'GLA5PR-101', 'briefTitle': 'A Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS Tablet 150mg With Immediate Release Formulation and to Assess The Effect of High Fat Diet in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'GL Pharm Tech Corporation'}, 'officialTitle': 'A Randomized, Open-label, 3-way Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS Tablet 150mg With Immediate Release Formulation and to Assess The Effect of High Fat Diet in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'GLA5PR-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GLA5PR GLARS tablet 150mg(fasted)', 'interventionNames': ['Drug: Pregabalin']}, {'type': 'EXPERIMENTAL', 'label': 'GLA5PR GLARS tablet 150mg(after high fat meal)', 'interventionNames': ['Drug: Pregabalin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lyrica Capsule 75mg(fasted)', 'interventionNames': ['Drug: Pregabalin']}], 'interventions': [{'name': 'Pregabalin', 'type': 'DRUG', 'description': 'GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, fasted)', 'armGroupLabels': ['GLA5PR GLARS tablet 150mg(fasted)']}, {'name': 'Pregabalin', 'type': 'DRUG', 'description': 'GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after high fat meal)', 'armGroupLabels': ['GLA5PR GLARS tablet 150mg(after high fat meal)']}, {'name': 'Pregabalin', 'type': 'DRUG', 'description': 'Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, fasted)', 'armGroupLabels': ['Lyrica Capsule 75mg(fasted)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '137-701', 'city': 'Seochogu', 'state': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Seoul St.Mary's Hospital"}], 'overallOfficials': [{'name': 'Dong-seok Yim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Catholic University of Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GL Pharm Tech Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}