Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2026-01-09 @ 6:12 AM
Study NCT ID:
NCT07231861
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of AJU-R713 and R713R in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax of Pranlukast', 'timeFrame': '0 hour ~ 24 hour after drug administration', 'description': 'To assess the maximum observed plasma concentration (Cmax) of Pranlukast'}, {'measure': 'AUCt of Pranlukast', 'timeFrame': '0 hour ~ 24 hour after drug administration', 'description': 'To assess the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Pranlukast'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bronchial Asthma', 'Perennial Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'To Evaluate the Safety and Pharmacokinetics of Pranlukast hydrate in Healthy Adults.', 'detailedDescription': 'This study evaluates the pharmacokinetic characteristics and safety of pranlukast in healthy adults. It is a randomized, open-label, single-dose, two-period crossover trial conducted under fasting conditions. Pharmacokinetic samples are collected up to 24 hours after dosing, and standard safety assessments are performed throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults aged 19 years or older at the time of screening.\n* Body mass index (BMI) between 18 and 30 kg/m².\n\n * Male subjects: body weight ≥ 50 kg.\n * Female subjects: body weight ≥ 45 kg.\n* Clinically healthy based on medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory test results, as determined by the investigator.\n* Willing and able to provide written informed consent after receiving a full explanation of the study.\n* Subjects (and their partners, if applicable) agree to use highly effective, non-hormonal contraception from the first dosing day until one week after the last dose.\n\nExclusion Criteria:\n\n* Use of drugs known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or any medication likely to interfere with the study within 10 days prior to dosing.\n* Participation in any clinical trial involving investigational products within 6 months prior to the first dose.\n* Whole blood donation within 8 weeks, or component blood donation within 2 weeks prior to the first dose.\n* History of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair).\n* Known hypersensitivity to the investigational product or its components.\n* Known metabolic or genetic disorders such as galactose intolerance, lactase deficiency, glucose-galactose malabsorption, or phenylketonuria.\n* History of clinically significant psychiatric illness.\n* Pregnant or breastfeeding women, or women with a possibility of pregnancy.'}, 'identificationModule': {'nctId': 'NCT07231861', 'briefTitle': 'Bioequivalence Study of AJU-R713 and R713R in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'AJU Pharm Co., Ltd.'}, 'officialTitle': 'An Open-Label, Randomized, Fasting, Single-Dose, Two-Sequence, Two-Period Crossover Study to Evaluate the Bioequivalence of "AJU-R713" and "R713R" in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': '25BA11701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pranlukast Test Formulation', 'description': 'Two-period, single-dose, crossover study', 'interventionNames': ['Drug: AJU-R713', 'Drug: R713R']}, {'type': 'EXPERIMENTAL', 'label': 'Pranlukast Reference Formulation', 'description': 'Two-period, single-dose, crossover study (reversed order)', 'interventionNames': ['Drug: AJU-R713', 'Drug: R713R']}], 'interventions': [{'name': 'AJU-R713', 'type': 'DRUG', 'description': 'Oral formulation', 'armGroupLabels': ['Pranlukast Reference Formulation', 'Pranlukast Test Formulation']}, {'name': 'R713R', 'type': 'DRUG', 'description': 'Oral formulation', 'armGroupLabels': ['Pranlukast Reference Formulation', 'Pranlukast Test Formulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08779', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'H Plus Yangji Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Heejoo Hong', 'role': 'CONTACT', 'email': 'm4688@newyjh.com', 'phone': '+82-70-4665-9156'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AJU Pharm Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}