Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT05874167
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2023-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pharmacokinetic Study of DW6013 (FDC of Linagliptin and Metformin) in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C585596', 'term': 'Jentadueto'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-16', 'studyFirstSubmitDate': '2023-04-06', 'studyFirstSubmitQcDate': '2023-05-16', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-t', 'timeFrame': 'up to 72 hours', 'description': 'AUC0-t of Linagliptin and Metformin'}, {'measure': 'Cmax', 'timeFrame': 'up to 72 hours', 'description': 'Cmax of Linagliptin and Metformin'}], 'secondaryOutcomes': [{'measure': 'Tmax', 'timeFrame': 'up to 72 hours', 'description': 'Tmax of Linagliptin and Metformin'}, {'measure': 'AUCinf', 'timeFrame': 'up to 72 hours', 'description': 'AUCinf of Linagliptin and Metformin'}, {'measure': 'AUCextra', 'timeFrame': 'up to 72 hours', 'description': 'AUCextra of Linagliptin and Metformin'}, {'measure': 't1/2', 'timeFrame': 'up to 72 hours', 'description': 't1/2 of Linagliptin and Metformin'}, {'measure': 'CL/F', 'timeFrame': 'up to 72 hours', 'description': 'CL/F of Linagliptin and Metformin'}, {'measure': 'Vd/F', 'timeFrame': 'up to 72 hours', 'description': 'Vd/F of Linagliptin and Metformin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of DW6013 and each component in healthy adult volunteers in fast condition.', 'detailedDescription': 'This is a Phase 1, randomized, open-label, Oral, Single-dose, two-way crossover study in healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy subjects aged up to 19 years\n* Subjects weighing at least 50.0 kg and no more than 100 kg (inclusive) with a BMI between 18.5 kg/m2 and 30.0 kg/m2\n* Subjects with neither congenital nor chronic diseases requiring treatment, and no abnormal symptoms or findings upon medical examination\n* Subjects considered eligible for the study participation in accordance to the results of clinical laboratory tests, vital signs, physical examinations and 12-lead ECG conducted at the time of screening, based on the investigational product (IP) characteristics\n* Subjects who has a full understanding in participation of the study, voluntarily provide a written consent in participation, and give full agreement in following the subject guidelines throughout the entire study period\n\nExclusion Criteria:\n\n* Subjects with any clinically significant hepatic, renal, nervous, respiratory, endocrine, circulatory, tumor, genitourinary, cardiovascular, digestive, musculoskeletal systemic diseases or other medical history\n* Pregnant subjects with a positive urine HCG test, or lactating female subjects\n* Subjects taking drugs known to significantly induce or inhibit drug metabolizing enzymes, including barbitals within 1 months prior to the first IP administration\n* Subjects with clinically significant 12-lead ECG findings at the time of screening\n* Subjects with a past history of drug abuse or a positive urine drug test\n* Subjects with SBP ≥ 150 mmHg or ≤ 90 mmHg; DBP ≥ 100 mmHg or ≤ 60 mmHg; PR ≤ 40 bpm or ≥ 100 bpm at the time of screening\n* Subjects following an unusual diet or consumption of food which may affect the absorption, distribution, metabolism and excretion of the IP\n* Subjects who have administered any prescription drugs or herbal medicines that may affect the characteristics of clinical investigational drugs within 2 weeks prior to the first administration date, or have administered any over-the-counter (OTC) or vitamin preparations within 10 days\n* Subjects who have participated and were given any other study drugs in other clinical study within 6 months prior to the first IP administration\n* Subjects who have consistently drunk alcohol within 6 months\n* Subjects who have smoked more than 10 cigarettes/day on average\n* Subjects who have eaten or cannot refrain from eating grapefruit (grapefruit)-containing food from 48 hours before the first administration until the time of PSV\n* Subjects who have consumed or cannot refrain from consuming caffeine-containing food during the period from 24 hours prior to administration of each period to the time of the last blood sampling\n* Subjects who have done and are unable to refrain from strenuous activity\n* Subjects who are planning for pregnancy or not willing to use a medically reliable forms of contraception\n* Subjects otherwise considered ineligible for participation due to other reasons including clinical laboratory test results not mentioned in the inclusion/exclusion criteria at the investigator's discretion"}, 'identificationModule': {'nctId': 'NCT05874167', 'briefTitle': 'A Pharmacokinetic Study of DW6013 (FDC of Linagliptin and Metformin) in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong Wha Pharmaceutical Co. Ltd.'}, 'officialTitle': 'A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of Fixed-dose Combination of DW6013 and Loose Combination of Each Component in Healthy Adult Volunteers in Fast Condition', 'orgStudyIdInfo': {'id': 'DW6013-I-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence A', 'description': 'Period 1: Linagliptin and Metformin / Period 2: DW6013', 'interventionNames': ['Drug: DW6013']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence B', 'description': 'Period 1: DW6013 / Period 2: Linagliptin and Metformin', 'interventionNames': ['Drug: DW6013']}], 'interventions': [{'name': 'DW6013', 'type': 'DRUG', 'otherNames': ['Linagliptin and Metformin'], 'description': 'Drug: DW6013 Single oral administration of DW6013 after an overnight fast\n\nDrug: Linagliptin and Metformin Single oral administration of Linagliptin and Metformin after an overnight fast', 'armGroupLabels': ['Sequence A', 'Sequence B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cheongju-si', 'country': 'South Korea', 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong Wha Pharmaceutical Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}