Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-03-05 @ 8:30 AM
Study NCT ID:
NCT03261427
Status:
COMPLETED
Last Update Posted:
2019-07-10
First Post:
2017-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}, {'id': 'D013607', 'term': 'Tablets'}], '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'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-08', 'studyFirstSubmitDate': '2017-08-22', 'studyFirstSubmitQcDate': '2017-08-24', 'lastUpdatePostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part I : AUClast of Pregabalin', 'timeFrame': '0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours'}, {'measure': 'Part I : Cmax of Pregabalin', 'timeFrame': '0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours'}, {'measure': 'Part II : AUCτ,ss of Pregabalin', 'timeFrame': 'Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours'}, {'measure': 'Part II : Cmax,ss of Pregabalin', 'timeFrame': 'Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours'}], 'secondaryOutcomes': [{'measure': 'Part I : AUCinf of Pregabalin', 'timeFrame': '0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours'}, {'measure': 'Part I : Tmax of Pregabalin', 'timeFrame': '0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours'}, {'measure': 'Part I : t1/2 of Pregabalin', 'timeFrame': '0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours'}, {'measure': 'Part I : Vd/F of Pregabalin', 'timeFrame': '0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours'}, {'measure': 'Part I : CL/F of Pregabalin', 'timeFrame': '0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours'}, {'measure': 'Part II : Cmin,ss of Pregabalin', 'timeFrame': 'Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours'}, {'measure': 'Part II : AUClast,ss of Pregabalin', 'timeFrame': 'Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours'}, {'measure': 'Part II : Tmax,ss of Pregabalin', 'timeFrame': 'Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours'}, {'measure': 'Part II : t1/2 of Pregabalin', 'timeFrame': 'Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours'}, {'measure': 'Part II : CLss/F of Pregabalin', 'timeFrame': 'Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours'}, {'measure': 'Part II : Vdss/F of Pregabalin', 'timeFrame': 'Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours'}, {'measure': 'Part II : accumulation ratio(Cmax) of Pregabalin', 'timeFrame': 'Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours'}, {'measure': 'Part II : accumulation ratio(AUCτ) of Pregabalin', 'timeFrame': 'Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial to compare the pharmacokinetic characteristics of YNP-1807(Pregabalin 330mg) and Lyrica capsule(Pregabalin 150mg). YNP-1807 is made by Yungjin Pharm. Primary endpoints are AUClast and Cmax and secondary endpoints are AUCinf, Tmax, t1/2, Vd/f, CL/f.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19 years to 55 years healthy volunteers adult at screening visit\n* For male, weight is more than 55 kg, for female, weight is more than 50 kg.\n* Body mass index(BMI) value : 18.5 to 25.0 kg/m2\n* If female, should be included one at least as following\n\n * menopausal(menstruation for 2 years minimum)\n * surgery infertility\n\nExclusion Criteria:\n\n* Any history of drug overdose or dependence\n* Female who is pregnant or nursing\n* AST, ALT \\> ULN\\*1.25\n* Total bilirubin \\> ULN\\*1.5\n* CPK \\> ULN\\*1.5'}, 'identificationModule': {'nctId': 'NCT03261427', 'briefTitle': 'Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yungjin Pharm. Co., Ltd.'}, 'officialTitle': 'A Randomized, Open-label, Phase I Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration in Healthy Adult Volunteers: Part I- Single Dosing/Part II- Multiple Dosing', 'orgStudyIdInfo': {'id': 'YJ16-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YNP-1807 Tablet(Pregabalin 330mg)', 'description': 'YNP-1807(Pregabalin 330mg), QD', 'interventionNames': ['Drug: YNP-1807 330Mg Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lyrica Capsule(Pregabalin 150mg)', 'description': 'Lyrica Capsule(Pregabalin 150mg), BID', 'interventionNames': ['Drug: Lyrica 150Mg Capsule']}], 'interventions': [{'name': 'Lyrica 150Mg Capsule', 'type': 'DRUG', 'description': '150 mg oral administered (BID)', 'armGroupLabels': ['Lyrica Capsule(Pregabalin 150mg)']}, {'name': 'YNP-1807 330Mg Tablet', 'type': 'DRUG', 'description': '330 mg oral administered (QD)', 'armGroupLabels': ['YNP-1807 Tablet(Pregabalin 330mg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Yonsei-ro Seodaemun-gu', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'MinSoo Park, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital, Seoul, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yungjin Pharm. Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}