Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-02 @ 9:13 AM
Study NCT ID:
NCT02426151
Status:
COMPLETED
Last Update Posted:
2016-03-18
First Post:
2015-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence of a Single Subcutaneous Dose of BEPO and REPO in Healthy Male 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': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-17', 'studyFirstSubmitDate': '2015-04-21', 'studyFirstSubmitQcDate': '2015-04-23', 'lastUpdatePostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax and AUClast', 'timeFrame': '1D before dosing, 1h, 2, 4h, 7h, 10h,12h, 14h, 2D 0h, 2D 8h, 3D 0h, 4D 0h, 5D 0h, 6D 0h,'}], 'secondaryOutcomes': [{'measure': 'AUCinf, Tmax, t1/2β, CL/F, MRTinf (mean residence time) of Erythropoietin', 'timeFrame': '1D before dosing, 1h, 2, 4h, 7h, 10h,12h, 14h, 2D 0h, 2D 8h, 3D 0h, 4D 0h, 5D 0h, 6D 0h,'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To Compare Pharmacokinetic and Pharmacodynamic Profiles of BEPO-A and REPO-A in Healthy Male Subjects', 'detailedDescription': 'To Compare Pharmacokinetic and Pharmacodynamic Profiles of EPO (BEPO-A (4000 IU)) and EPO (REPO-A (4000 IU)) in Healthy Male Subjects'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Agree to all the purposes of the study by signing and dating the Informed Consent;\n* Male, aged between 19 and 40 years, clinically healthy;\n* BMI between 19 and 28;\n* 90 mmHg ≤ SBP \\<140 mmHg, 50 mmHg ≤ DBP \\< 85 mmHg\n\nExclusion Criteria:\n\n* Hemoglobin \\<13 g / dL\n* Ferritin \\<20 ng/mL or TIBC \\> 360 ug/ dL\n* Vitamin B12 \\< 200 pg/mL or floate \\< 4 ng/mL\n* %reticulpcyte \\> 3%\n* platelet \\< 100,000/ul or \\> 400,000/ul\n* GFR \\< 60mL/min/1.73m2\n* Going to or during treatment of the tumor\n* Clinical history of allergy of biological products derived from mammalian albumin or any component of the formulation\n* Clinical history of autoimmune or hereditary anemia\n* A Positive reaction in the nicotine tests\n* Principal Investigator of the study criteria.'}, 'identificationModule': {'nctId': 'NCT02426151', 'briefTitle': 'Bioequivalence of a Single Subcutaneous Dose of BEPO and REPO in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Life Sciences'}, 'officialTitle': 'A Randomized, Open Label, Single-dose 2x2 Crossover Study to Compare Pharmacokinetic, Pharmacodynamic Profiles, and Tolerability of EPO (BEPO-A (4000 IU)) and EPO (REPO-A (4000 IU)) in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'LG-EPCL009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BEPO-A', 'description': 'Single subcutaneous injection of BEPO-A 4000 IU (Bioreactor manufacturing process)', 'interventionNames': ['Drug: BEPO-A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'REPO-A', 'description': 'Single subcutaneous injection of REPO-A 4000 IU (Roller bottle manufacturing process)', 'interventionNames': ['Drug: REPO-A']}], 'interventions': [{'name': 'BEPO-A', 'type': 'DRUG', 'description': 'BEPO-A (Bioreactor manufacturing process)', 'armGroupLabels': ['BEPO-A']}, {'name': 'REPO-A', 'type': 'DRUG', 'description': 'REPO-A (Roller bottle manufacturing process)', 'armGroupLabels': ['REPO-A']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Life Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}