Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT04438720
Status:
UNKNOWN
Last Update Posted:
2020-08-21
First Post:
2020-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-20', 'studyFirstSubmitDate': '2020-06-17', 'studyFirstSubmitQcDate': '2020-06-17', 'lastUpdatePostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': '60 days', 'description': 'Evaluation of Peak Plasma Concentration (Cmax)'}, {'measure': 'Area under the plasma concentration versus time curve (AUC)0-t', 'timeFrame': '60 days', 'description': 'Evaluation of Area under the plasma concentration versus time curve (AUC)0-t'}, {'measure': 'Area under the plasma concentration versus time curve (AUC)0-∞', 'timeFrame': '60 days', 'description': 'Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞'}], 'secondaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': '60 days', 'description': 'Collection of adverse events'}, {'measure': 'Incidence of abnormal blood pressure', 'timeFrame': '60 days', 'description': 'Monitor both systolic and diastolic blood pressure'}, {'measure': 'Incidence of abnormal temperature', 'timeFrame': '60 days', 'description': 'Monitor the temperature'}, {'measure': 'Incidence of abnormal pulse', 'timeFrame': '60 days', 'description': 'Temperature the pulse'}, {'measure': 'Incidence of abnormal electrocardiogram waveform', 'timeFrame': '60 days', 'description': 'Electrocardiogram inspection'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Extended Release Nifedipine Tablets'], 'conditions': ['Therapeutic Equivalency']}, 'descriptionModule': {'briefSummary': 'According to the relevant provisions of bioequivalence test, nifedipine sustained-release tablets (test preparation, t, 30mg / tablet) provided by Guangzhou bostao controlled release pharmaceutical Co., Ltd. were compared with Adalat ® GITS (reference preparation, R, 30mg / tablet) produced by Bayer Pharma AG to evaluate the bioequivalence of single dose in healthy subjects under fasting conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male or female aged 18-45.\n* The body mass index is in the range of 18.6-28.5 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg.\n* The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test.\n* The subjects have no family planning within 3 months and could select contraceptive method.\n* Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.\n\nExclusion Criteria:\n\n* Being allergy to the study medications, smoking, alcohol abuse.\n* Participation in another clinical trial within 3 months."}, 'identificationModule': {'nctId': 'NCT04438720', 'briefTitle': 'Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Qingdao University'}, 'officialTitle': 'Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects: A Single-dose and Two-period Crossover Study', 'orgStudyIdInfo': {'id': 'Awk-2019-BE-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Extended Release Nifedipine Tablets（Adalat® GITS）', 'description': 'Extended Release Nifedipine reference formulation at a single dose of 30 mg', 'interventionNames': ['Drug: Extended Release Nifedipine Tablets 30 mg (Adalat® GITS)']}, {'type': 'EXPERIMENTAL', 'label': 'Extended Release Nifedipine Tablets', 'description': 'Extended Release Nifedipine test formulation at a single dose of 30 mg', 'interventionNames': ['Drug: Extended Release Nifedipine Tablets 30 mg']}], 'interventions': [{'name': 'Extended Release Nifedipine Tablets 30 mg', 'type': 'DRUG', 'description': 'The subjects randomly received single oral administration of extended release nifedipine tablets 30 mg.', 'armGroupLabels': ['Extended Release Nifedipine Tablets']}, {'name': 'Extended Release Nifedipine Tablets 30 mg (Adalat® GITS)', 'type': 'DRUG', 'description': 'The subjects randomly received single oral administration of extended release nifedipine tablets 30 mg.', 'armGroupLabels': ['Extended Release Nifedipine Tablets（Adalat® GITS）']}]}, 'contactsLocationsModule': {'locations': [{'zip': '266003', 'city': 'Qingdao', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yu Cao, doctor', 'role': 'CONTACT', 'email': 'caoyu1767@126.com', 'phone': '86 18661809090'}, {'name': 'ye Tao, master', 'role': 'CONTACT', 'email': 'taoye165298765@163.com', 'phone': '86 17853287551'}], 'facility': 'Phase I Clinical Research Center', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}], 'centralContacts': [{'name': 'Yu Cao', 'role': 'CONTACT', 'email': 'caoyu1767@126.com', 'phone': '+86 18661809090'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cao Yu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, Head of Phase I clinical research center, Principal Investigator, Clinical Professor.', 'investigatorFullName': 'Cao Yu', 'investigatorAffiliation': 'The Affiliated Hospital of Qingdao University'}}}}