Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT03329118
Status:
UNKNOWN
Last Update Posted:
2017-11-09
First Post:
2017-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug-drug Interaction Between Simvastatin and SHR3824
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000611095', 'term': 'henagliflozin'}, {'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-11-24', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-12-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-07', 'studyFirstSubmitDate': '2017-10-30', 'studyFirstSubmitQcDate': '2017-10-31', 'lastUpdatePostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The maximum plasma concentration (Cmax) of SHR3824', 'timeFrame': 'At protocol-specified times up to Day 7 and Day 8', 'description': "Cmax (a measure of the body's exposure to SHR3824) will be compared before and after coadministration with Simvastatin ."}, {'measure': 'The area under the plasma concentration-time curve (AUC) of SHR3824', 'timeFrame': 'At protocol-specified times up to Day 7 and Day 8', 'description': "AUC(a measure of the body's exposure to SHR3824) will be compared before and after coadministration with Simvastatin ."}, {'measure': 'The area under the plasma concentration-time curve (AUC) of Simvastatin and simavastatin acid .', 'timeFrame': 'At protocol-specified times up to Day 1 and Day 8', 'description': "AUC(a measure of the body's exposure to simvastatin and simavastatin acid) will be compared before and after coadministration with SHR3824 ."}, {'measure': 'The maximum plasma concentration (Cmax) of simvastatin and simavastatin acid.', 'timeFrame': 'At protocol-specified times up to Day 1 and Day 8', 'description': "Cmax (a measure of the body's exposure to simvastatin and simavastatin acid) will be compared before and after coadministration with Simvastatin ."}, {'measure': 'The number of volunteers with adverse events as a measure of safety and tolerability.', 'timeFrame': 'up to day 15'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SHR3824,simvastatin, drug-drug interaction'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'the purpose of thr study is to investigate the potential interation between multiple oral doses of SHR3824 and single oral dose of Simvastatin in healthy adult volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2\n\nExclusion Criteria:\n\n* History of hypoglycemia\n* History of urinary tract infections,or genital infections\n* History of current clinically significant medical illness as determined by the Investigator\n* Known allergy to SHR3824 or Simvastatin or any of the excipients of the formulation of SHR3824 or Simvastatin"}, 'identificationModule': {'nctId': 'NCT03329118', 'briefTitle': 'Drug-drug Interaction Between Simvastatin and SHR3824', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'Drug Interaction Study of Henagliflozin and Simvastatin in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'SHR3824-111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR3824 1Omg,Simavastatin 40mg', 'description': 'two 20mg tablets of simvastatin once daily on Day 1 followed by one 10mg tablet of SHR3824 once daily on Day 4,5,6,7,followed by two 20mg tablets of simvastatin and one 10mg tablet of SHR3824 on Day 8.', 'interventionNames': ['Drug: SHR3824, Simvastatin']}], 'interventions': [{'name': 'SHR3824, Simvastatin', 'type': 'DRUG', 'description': 'two 20mg tablets of simvastatin once daily on Day 1 followed by one 10mg tablet of SHR3824 once daily on Day 4,5,6,7,followed by two 20mg tablets of simvastatin and one 10mg tablet of SHR3824 on Day 8.', 'armGroupLabels': ['SHR3824 1Omg,Simavastatin 40mg']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Haiyan Liu, PhD', 'role': 'CONTACT', 'email': 'liuhaiyan@shhrp.com', 'phone': '+86-15705155025'}, {'name': 'Jian Chen, Master', 'role': 'CONTACT', 'email': 'zrygcp@126.com', 'phone': '+86-13588084969'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}