Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-02-27 @ 10:39 AM
Study NCT ID:
NCT03483259
Status:
COMPLETED
Last Update Posted:
2018-11-13
First Post:
2018-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000717729', 'term': 'surufatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Eligible subjects who did not meet the exclusion criteria were randomly assigned to one of the three groups: group A, B, and C (administration TRR, RTR and RRT, 9 subjects in each group, where T is the test formulation and R is the reference formulation) .'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-08', 'studyFirstSubmitDate': '2018-03-08', 'studyFirstSubmitQcDate': '2018-03-23', 'lastUpdatePostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) of Sulfatinib', 'timeFrame': 'Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5', 'description': 'The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration.'}, {'measure': 'Maximum observed plasma concentration (Cmax) of Sulfatinib', 'timeFrame': 'Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5', 'description': 'Maximum observed concentration, occurring at Tmax.'}, {'measure': 'The time to Cmax (peak time, Tmax) of Sulfatinib', 'timeFrame': 'Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5', 'description': 'The time at which maximum plasma concentration (Cmax) is observed.'}, {'measure': 'Half-life (t1/2) of Sulfatinib', 'timeFrame': 'Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5', 'description': 'The time required for the concentration of the drug to reach half of its original value.'}, {'measure': 'Relative Bioavailability', 'timeFrame': 'Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5', 'description': 'This term represents the relationship between the bioavailability of a substance in two different media.'}], 'secondaryOutcomes': [{'measure': 'Adverse Event (AE) monitoring of Sulfatinib', 'timeFrame': 'Measured from the date signed ICF to within 14 days after the last dose', 'description': 'AE monitoring will be assessed by incidence of AEs, AE grading, serious AEs, as well as laboratory determinations and vital sign parameters.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics', 'Relative bioavailability'], 'conditions': ['Relative Bioavailability']}, 'descriptionModule': {'briefSummary': 'This is a single-center, randomized, open, single-dose, three-cycle cross-design study, which will be only enrolled Chinese male healthy volunteers.', 'detailedDescription': '27-30 Chinese male healthy volunteers will be enrolled to assess the pharmacokinetic profile and relative bioavailability of 300 mg (50 mg x 6) Sulfatinib capsules of single dose orally in two different manufacturers after breakfast. All subjects are required to collect PK blood samples before and after administration at the following time points: within 1 hour before administration, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours after administration (16 times point), each collection of venous blood is 2mL.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects must be voluntary and sign an informed consent form and agree to comply with the requirements of the protocol；\n2. Age of 18-40 (inclusive), male healthy volunteers；\n3. Medical history, physical examination, 12-lead ECG and laboratory tests at screening judged as normal or abnormal but not clinically significant by investigators;\n4. Medical history, physical examination, 12-lead ECG and laboratory tests at screening judged as normal or abnormal but not clinically significant by investigators;\n5. Men whose partners are women of childbearing potential are required to use adequate contraceptive methods during participation in this study；\n\nExclusion Criteria:\n\n1. Any clinically significant disease or condition includes but not limited to metabolism/endocrine, liver, kidney, blood, lung, immune, cardiovascular, gastrointestinal, genito-urinary, nervous, or mental illness that judged by the investigator within 3 months before screening;\n2. Previous gastrointestinal surgery, kidney surgery, cholecystectomy and surgery history may affect the absorption or excretion of drugs;\n3. Hypertension: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg;\n4. Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) test positive, HIV or treponema pallidum antibodies test positive;\n5. Any drugs that may change the liver and kidney clearance;\n6. Take any prescription drug (including Chinese herbal medicine) within 14 days before dosing; or use any over-the-counter drugs (including but not limited to vitamins, prophylaxis, plant health products) within 7 days before dosing;\n7. Clinical trials of other medications before screening, less than a 5-fold half-life or 28 days from the time of the last other study drug, whichever is longer;\n8. Any history of clinically serious disease or condition that the investigator believes may affect the outcome of this study.'}, 'identificationModule': {'nctId': 'NCT03483259', 'acronym': 'CRC-C1721', 'briefTitle': 'To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hutchmed'}, 'officialTitle': 'To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers in Chinese Adult Male Healthy Volunteers', 'orgStudyIdInfo': {'id': '2016-012-00CH2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A-Sulfatinib T capsule', 'description': 'The subjects in this arm will receive sulfatinib T capsules from Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd.', 'interventionNames': ['Drug: Sulfatinib T capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B-Sulfatinib R capsule', 'description': 'The subjects in this arm will receive sulfatinib R capsules from Beijing Yiling Bioengineering Technology Co., Ltd.', 'interventionNames': ['Drug: Sulfatinib R capsule']}], 'interventions': [{'name': 'Sulfatinib T capsule', 'type': 'DRUG', 'otherNames': ['HMPL-012, Surufatinib'], 'description': 'Sulfatinib T capsules were produced by Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd. production.', 'armGroupLabels': ['Arm A-Sulfatinib T capsule']}, {'name': 'Sulfatinib R capsule', 'type': 'DRUG', 'otherNames': ['HMPL-012, Surufatinib'], 'description': 'Sulfatinib R capsules were produced by Beijing Yiling Bioengineering Technology Co., Ltd.', 'armGroupLabels': ['Arm B-Sulfatinib R capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200031', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Xuhui District Central Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Liu Yanmei, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Xuhui District Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hutchison Medipharma Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}