Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-30 @ 5:29 AM
Study NCT ID:
NCT04328506
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
2020-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalency Study of CM082 Tablet in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000709220', 'term': 'vorolanib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-24', 'studyFirstSubmitDate': '2020-03-26', 'studyFirstSubmitQcDate': '2020-03-30', 'lastUpdatePostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak plasma concentration(Cmax) of CM082 (test product or reference product) under fasted state or after meal', 'timeFrame': 'pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour]', 'description': 'The Cmax ofCM082 (test product or reference product) in under fasted state or after meal blood samples of each subject over a 72 hour period post dose'}, {'measure': 'Area under the plasma concentration versus time curve(AUC) of CM082 (test product or reference product) under fasted state or after meal', 'timeFrame': 'pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour]', 'description': 'The AUC of CM082 (test product or reference product) in under fasted state or after meal blood samples of each subject over a 72 hour period post dose'}, {'measure': 'Time of maximum concentration (Tmax) of CM082 (test product or reference product) under fasted state or after meal', 'timeFrame': 'pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour]', 'description': 'The Tmax of CM082 (test product or reference product) in under fasted state or after meal blood samples of each subject over a 72 hour period post dose'}], 'secondaryOutcomes': [{'measure': 'Percentage of adverse events', 'timeFrame': 'From the first occurrence of adverse events after administration to the cessation of adverse events, assessed up to 2 months', 'description': 'Percentage of adverse events as assessed by CTCAE v4.03'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Malignant Solid Tumors']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers.', 'detailedDescription': 'The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers under fasted state or after meal. In addition, the safety of single dose administration of CM082 tablet in Chinese healthy volunteers will also be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male body weight≥50.0kg or female body weight≥45.0kg; BMI between 19.0-26.0 kg/m2(inclusive)\n* Generally in good health, with no history of chronic disease or sever disease\n* No (clinical significant) abnormal findings in clinical laboratory tests and physical examinations\n* No plan for pregnancy in coming 6 months, and must practice effective contraception; No plan for sperm or egg donation\n* Written informed consent\n\nExclusion Criteria:\n\n* History of food or drug allergies\n* Clinical significant disease or disorders\n* Received surgery in 3 months before screening, or have plan for surgery during the study\n* Participated in other clinical trials within 3 months before screening\n* Intolerant of venipuncture, history of fainting needle and blood\n* Lactose intolerant\n* Drug abusing in 3 months\n* Donated ≥200 mL of blood within 3 months before screening\n* Pregnant or under lactation period (female subjects)\n* Received any prescription drug, over-the-counter drug, prescription drug and Chinese herbal drug in 2 weeks, with the exception of vitamins and acetaminophen\n* Received any vaccine in 4 weeks\n* Excessively smoking, alcohol or coffin-containing beverage drinking in 3 months\n* Other circumstances that is deemed not appropriate for the study'}, 'identificationModule': {'nctId': 'NCT04328506', 'briefTitle': 'Bioequivalency Study of CM082 Tablet in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'AnewPharma'}, 'officialTitle': 'Randomized,Open Label,Two-cycle,Crossover,Single Dose Bioequivalency Study of Two Preparations of CM082 Tablet in Healthy Chinese Volunteers Under Fasted State and After Meal', 'orgStudyIdInfo': {'id': 'CM082-CA-I-108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T-R cohort under fasted state', 'description': 'Subjects will be administered with one single dose of CM082 tablet (test product) under fasted state, after a wash period of 5 days, the subjects will be administered with one single dose of CM082 tablet (reference product) under fasted state.', 'interventionNames': ['Drug: CM082 tablet (test product)', 'Drug: CM082 tablet (reference product)']}, {'type': 'EXPERIMENTAL', 'label': 'R-T cohort under fasted state', 'description': 'Subjects will be administered with one single dose of CM082 tablet (reference product) under fasted state, after a wash period of 5 days,the subjects will be administered with one single dose of CM082 tablet (test product) under fasted state.', 'interventionNames': ['Drug: CM082 tablet (test product)', 'Drug: CM082 tablet (reference product)']}, {'type': 'EXPERIMENTAL', 'label': 'T-R cohort after meal', 'description': 'Subjects will be administered with one single dose of CM082 tablet (test product) after meal, after a wash period of 5 days,the subjects will be administered with one single dose of CM082 tablet (reference product) after meal.', 'interventionNames': ['Drug: CM082 tablet (test product)', 'Drug: CM082 tablet (reference product)']}, {'type': 'EXPERIMENTAL', 'label': 'R-T cohort after meal', 'description': 'Subjects will be administered with one single dose of CM082 tablet (reference product) after meal, after a wash period of 14 days,the subjects will be administered with one single dose of CM082 tablet (test product) after meal', 'interventionNames': ['Drug: CM082 tablet (test product)', 'Drug: CM082 tablet (reference product)']}], 'interventions': [{'name': 'CM082 tablet (test product)', 'type': 'DRUG', 'description': 'Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals', 'armGroupLabels': ['R-T cohort after meal', 'R-T cohort under fasted state', 'T-R cohort after meal', 'T-R cohort under fasted state']}, {'name': 'CM082 tablet (reference product)', 'type': 'DRUG', 'description': 'Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions', 'armGroupLabels': ['R-T cohort after meal', 'R-T cohort under fasted state', 'T-R cohort after meal', 'T-R cohort under fasted state']}]}, 'contactsLocationsModule': {'locations': [{'zip': '311009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'zourong ruan', 'role': 'STUDY_CHAIR', 'affiliation': 'the Second Affiliated Hospital of Zhejiang University Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AnewPharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}