Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT06879132
Status:
COMPLETED
Last Update Posted:
2025-03-17
First Post:
2025-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Pharmacokinetics and Safety of BR3409 and Co-administration of BR3409-1 and BR3409-2 in Healthy Volunteers Under Fed Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2025-03-11', 'studyFirstSubmitQcDate': '2025-03-11', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCτ', 'timeFrame': '0~48 hours after administration', 'description': 'Area under the plasma drug concentration-time curve from 0 to time τ'}, {'measure': 'Cmax', 'timeFrame': '0~48 hours after administration', 'description': 'Maximum Concentration of Drug in Plasma'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to evaluate the pharmacokinetics and safety of BR3409 and co-administration of BR3409-1 and BR3409-2 in healthy volunteers Under Fed Conditions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Those have body mass index (BMI: weight(kg)/the square of {height(m)}) within the range of 18.0 to 30.0 at screening visit.\n\n * For men, Those who weigh 55 kg or more\n * For women, Those who weigh 50 kg or more\n* Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.\n* Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\\*(Except for hormone drugs) from the date of consent to 56 days after the last administration and disagree to provide their sperm or ovum.\n\n * Methods of contraception accepted in clinical trial: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.\n\nExclusion Criteria:\n\n* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days before the first administration date or have taken drugs concerned about affecting this clinical trial within 10 days before the first administration date. (However, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)\n* Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months before the first day of administration. (However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)\n* Those who have a medical history of gastrointestinal resection or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)\n* In the case of a female subject, those suspected pregnancy or pregnant woman, lactating woman."}, 'identificationModule': {'nctId': 'NCT06879132', 'briefTitle': 'A Study to Evaluate the Pharmacokinetics and Safety of BR3409 and Co-administration of BR3409-1 and BR3409-2 in Healthy Volunteers Under Fed Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boryung Pharmaceutical Co., Ltd'}, 'officialTitle': 'A Randomized, Open-label, Fed, Single Dose, Two-way Crossover Study to Evaluate the Pharmacokinetics and Safety of "BR3409" and Co-administration of "BR3409-1" and "BR3409-2" in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'BR-ELMC-CT-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BR3409', 'interventionNames': ['Drug: BR3409']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BR3409-1 + BR3409-2', 'interventionNames': ['Drug: BR3409-1', 'Drug: BR3409-2']}], 'interventions': [{'name': 'BR3409', 'type': 'DRUG', 'description': 'One tablet administered alone', 'armGroupLabels': ['BR3409']}, {'name': 'BR3409-1', 'type': 'DRUG', 'description': 'One tablet administered alone', 'armGroupLabels': ['BR3409-1 + BR3409-2']}, {'name': 'BR3409-2', 'type': 'DRUG', 'description': 'One tablet administered alone', 'armGroupLabels': ['BR3409-1 + BR3409-2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08779', 'city': 'Seoul', 'state': 'Gwanakgu', 'country': 'South Korea', 'facility': 'Clinical Research Center, H PLUS Yangji Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boryung Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}